MedWorm.com provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest items from the 'FDA Transparency Blog' source. Wed, 08 Feb 2012 07:07:08 +0100 http://www.medworm.com/index.php?rid=5494441&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F12%2F12%2Fcanadian-and-u-s-agencies-partner-to-modernize-food-safety%2F As Deputy Commissioner for Foods at the Food and Drug Administration, I led a delegation to Ottawa on October 21 to meet with officials from the Canadian Food Inspection Agency (CFIA) and Health Canada to discuss how to best cooperate on our efforts to modernize our respective food safety systems.  I also had the opportunity to hear from Canadian industry representatives on their ideas of how FDA could implement the Food Safety Modernization Act (FSMA) in the most efficient manner as we continue to protect public health.  This trip furthered our efforts to reach out and collaborate with our colleagues abroad who will be our partners as we put FSMA in place, especially those provisions concerning imported food. The trip also allowed both sides to step back and reflect on the importance of... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=5494441 Mon, 12 Dec 2011 18:17:38 +0100 5494441 http://www.medworm.com/index.php?rid=5456751&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F11%2F29%2Fupcoming-event-fda-basics-webinar-on-the-import-entry-process%2F American consumers increasingly rely of goods manufactured in foreign countries: in Fiscal Year 2011, roughly 24 million shipments of FDA-regulated products were imported into the US. Regulating that large volume of varied shipments is a complicated and unending task, and one of great importance in the realm of consumer protection. Every day there are FDA field investigators in offices throughout the country and in FDA headquarters dedicated to providing this consumer protection. The FDA will host a webinar “FDA’s Import Operations: How FDA regulates imported products”, Wednesday, November 30th at 11:00 AM ET. The featured speaker, John Verbeten, is a branch director for FDA’s Division of Import Operations and Policy and a former field investigator. He will give an overview... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=5456751 Tue, 29 Nov 2011 15:28:21 +0100 5456751 http://www.medworm.com/index.php?rid=5399928&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F11%2F08%2Ftalking-food-safety-in-minneapolis-2%2F It’s not every day that I have a chance to see first-hand what companies are doing to strengthen their food safety preventive practices, but that’s just what happened on a recent trip to Minneapolis. The facility tour we took is part of FDA’s continuing effort to hear from all stakeholders on the best ways for us to implement the Food Safety Modernization Act (FSMA). I was joined by several FDA colleagues working hard on implementing the new food safety law, as well as the commissioner and assistant commissioner of the Minnesota Department of Agriculture, the department’s director of the division of dairy and food inspection, and the chief science officer of the Grocery Manufacturers Association. We met with company executives, plant and shift managers, and those responsible for th... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=5399928 Tue, 08 Nov 2011 17:15:14 +0100 5399928 http://www.medworm.com/index.php?rid=5358705&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F10%2F26%2F1429%2F If you’ve been following this blog you know that earlier this year, President Obama issued Executive Order (EO) 13563 and outlined his plan to create a 21st-century regulatory system that is simpler and smarter and that protects the health and safety of the American people in a pragmatic and cost-effective way.  One of the goals of EO 13563 is to target rules already on the books and revise regulations that are out-of-date, unnecessary, excessively burdensome, or in conflict with other rules. On June 3, 2011, we announced, as part of the Department of Health and Human Services (HHS) retrospective review plan, that the first of our regulations to be reviewed under this EO would be the “Bar Code Rule.” You can see the HHS plan in its entirety at http://www.hhs.gov/open/execorders/1356... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=5358705 Wed, 26 Oct 2011 16:35:29 +0100 5358705 http://www.medworm.com/index.php?rid=5346689&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F10%2F24%2Ffulfilling-the-promise-of-the-food-safety-modernization-act-the-importance-of-stakeholder-engagement%2F Recently, I had the good fortune to fill in for an FDA colleague on a panel entitled, “Assuring the Safety of Imported Food” at the National Food Policy Conference, which is organized by the Consumer Federation of America. Participants at the conference included a broad spectrum of activists, public officials, nutrition professionals, farm and food industry representatives, and scientists who are interested in agriculture, food and nutrition policy.  The Food and Drug Administration Food Safety Modernization Act (FSMA) was one of the key areas of focus at the conference. Even though I was called from the audience to participate unexpectedly in the panel, I hoped my role as Vice-Chair of FDA’s FSMA Imports Implementation Team would stand me in good stead. Fortunately, the other panel... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=5346689 Mon, 24 Oct 2011 18:37:09 +0100 5346689 http://www.medworm.com/index.php?rid=5334866&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F10%2F18%2Fupcoming-event-webinar-on-fdas-medwatch-system-how-to-report-adverse-events%2F Did you know that you can report problems that you have had with drugs and other medical products to the FDA? Did you know that MedWatch can send safety alerts directly to you, as soon as they appear on the web site? The FDA will host a webinar “FDA’s MedWatch System: How to Report Adverse Events”. The featured speaker, Brenda Rose Pharm.D., a Health Programs Coordinator in FDA’s Office of Special Health Issues will give an overview and answer questions about how to report adverse events to MedWatch. The free 30 minute webinar will be held Thursday, October 20th at 11 AM ET. There are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA website following the presentation. Learn more about the webinar, including i... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=5334866 Tue, 18 Oct 2011 16:03:43 +0100 5334866 http://www.medworm.com/index.php?rid=5296411&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F10%2F06%2Ffdas-new-outbreak-director-learning-from-outbreaks-is-the-key%2F (from left to right) Dr. Eric Sampson, Office of the Commissioner; Jeff Farrar, Office of Foods; Commissioner Margaret Hamburg; Dr. Kathleen Gensheimer; Sherri McGarry, CORE Senior Advisor; Michael Taylor, Deputy Commissioner for Foods So, “jump feet first” is what I did this week on my first day as chief medical officer  and director of outbreaks for the FDA Coordinated Outbreak Response and Evaluation (CORE) Network. CORE, with a dedicated multi-disciplinary staff, is meant to provide a streamlined, integrated approach to how FDA not only responds to human and animal foodborne illness outbreaks, but how we improve surveillance and post-response efforts, to apply lessons learned and prevent future outbreaks.   When an outbreak happens, the CORE staff will decide the strategy of FDA... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=5296411 Thu, 06 Oct 2011 15:29:06 +0100 5296411 http://www.medworm.com/index.php?rid=5284888&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F10%2F03%2Fnew-transparency-report-focuses-on-enforcement-data%2F Today, FDA is releasing 8 new draft proposals in a report entitled “Food and Drug Administration Transparency Initiative:  Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency’s Compliance and Enforcement Data.” These draft proposals are focused on making FDA’s compliance and enforcement data more accessible and user-friendly, and they are part of our ongoing efforts to increase the transparency of FDA’s operations and decision-making. In developing these draft proposals, FDA met with the Environmental Protection Agency (EPA) and the Department of Labor (DOL), both of which have well-developed and well-regarded enforcement data websites (www.epa-echo.gov and http://ogesdw.dol.gov, respectively).  At these meetings, EPA and DOL sh... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=5284888 Mon, 03 Oct 2011 15:30:05 +0100 5284888 http://www.medworm.com/index.php?rid=5259912&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F09%2F28%2Fupcoming-event-fda-webinar-on-prescription-drug-shortages-september-30-at-11am-et%2F Do you know that in 2010 there were a record number of shortages of prescription drugs, and that in 2011, FDA continues to see an increasing number of shortages, especially those involving older sterile injectable drugs? As part of FDA Basics, FDA is hosting a webinar where you can learn how the agency helps reduce the impact of drug shortages for patients and our nation’s health care system. Captain Valerie Jensen, R.Ph., Associate Director for FDA’s Center for Drug Evaluation and Research’s (CDER’s) Drug Shortage Program, will discuss the extent of the current drug shortage issue and the importance of communication among FDA, drug manufacturers, health professionals, and the public, in helping to reduce its impact on public health. The free 30 minute webinar will be held Friday, ... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=5259912 Wed, 28 Sep 2011 17:47:49 +0100 5259912 http://www.medworm.com/index.php?rid=5160765&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F08%2F20%2Ffda-tells-farmers-we-need-to-learn-from-you%2F Michael R. Taylor, FDA and Bob Nolan, Deer Run Farms Last week, farmers from across the North and South forks of Suffolk county Long Island showed a group of us from the U.S. Departments of Agriculture and Health and Human Services, the Food and Drug Administration (FDA), and the New York State Department of Agriculture and Markets the incredible diversity of their farms and the challenges FDA faces in writing a “produce safety” rule.    Bob Nolan, who farms 30 acres with his son and uncle, invited us because he heard that we had walked the rows of other fresh fruit and vegetable farms across the country.  In fact, this was the 14th state we visited in the last year or so.  We have seen the orchards of Oregon, the vast vegetable fields of California, Amish farms in Ohio, irrigatio... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=5160765 Sat, 20 Aug 2011 01:48:29 +0100 5160765 http://www.medworm.com/index.php?rid=5160766&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F08%2F17%2Ffostering-innovation-through-better-science%2F Science is the backbone of everything we do at FDA.  Which is why today’s release of the agency’s Strategic Plan for Regulatory Science is a significant next step in the agency’s Regulatory Science Initiative, originally announced in October, 2010.  We are releasing the plan along with a podcast and a consumer article to make it easier for everyone to join this conversation about regulatory science and understand what this plan really means. “As new discoveries yield increasingly complex products,” says FDA Commissioner Margaret A. Hamburg, M.D. “this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy.  It positions us to foster innovation through better science without compromising our high safety standa... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=5160766 Wed, 17 Aug 2011 16:30:15 +0100 5160766 http://www.medworm.com/index.php?rid=5063176&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F07%2F26%2Fcheck-it-out-newly-redesigned-fda-track-dashboard-pages%2F FDA’s performance management system, FDA-TRACK, allows the public to follow the agency’s progress on a range of measures (see April 7 blog  post). We redesigned FDA-TRACK!  It has been a little over one year since the launch of the FDA-TRACK website.  After collecting web traffic data during this time, we decided to make some changes to the dashboard pages in hopes of improving your experience.  The changes include: Cleaner look-and-feel; Charts and options to overlay related measures; XML downloads; and “FDA-TRACK Indices” by program area, for easier access navigation to specific content. Check out these before and after shots: Before: After: Please visit any of the FDA-TRACK dashboard pages to see these changes. (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=5063176 Tue, 26 Jul 2011 12:10:21 +0100 5063176 http://www.medworm.com/index.php?rid=5019831&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F07%2F11%2Fthe-us-and-mexico-share-approaches-on-food-safety%2F In June, I had the opportunity to lead a delegation of food safety officials from the Food and Drug Administration to meet with our Mexican counterparts. The trip was part of a larger, proactive strategy to reach out to stakeholders, both domestic and foreign, to explain the background and implementation strategies for the new Food Safety Modernization Act (FSMA) and importantly, to listen to issues raised by stakeholders. Following Canada, Mexico is the largest exporter of foods to the United States. It was an exciting opportunity to meet with Mexican officials, not only to provide outreach on our new law, but also to gain a better understanding of Mexican food safety interests and challenges, and to identify areas for collaboration to further ensure the safety of foods for our respective... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=5019831 Mon, 11 Jul 2011 13:25:19 +0100 5019831 http://www.medworm.com/index.php?rid=4894556&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F06%2F03%2Fupdate-on-retrospective-review-of-fda-regulations%2F Earlier this year, President Obama issued Executive Order (EO) 13563 and outlined his plan to create a 21st-century regulatory system that is simpler and smarter and that protects the health and safety of the American people in a pragmatic and cost-effective way.  One goal of EO 13563 is to target rules already on the books to increase flexibility and remove regulations that are out-of-date, unnecessary, excessively burdensome, or in conflict with other rules. On May 26, in support of EO 13563, more than two dozen Federal agencies released plans that identified initiatives with the potential to eliminate tens of millions of hours in reporting burdens, and billions of dollars in regulatory costs.  FDA, as part of the Department of Health and Human Services (HHS), is included in the HHS Pr... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4894556 Fri, 03 Jun 2011 18:34:03 +0100 4894556 http://www.medworm.com/index.php?rid=4872884&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F05%2F26%2Fnew-sources-of-fda-enforcement-information-posted%2F Today, the FDA is implementing the first in a series of proposals to increase public understanding of the public health impact of FDA’s enforcement efforts, help inform companies’ efforts to comply with FDA requirements, increase company accountability to consumers and business partners, and help consumers make more informed decisions about the products they buy. This action stems directly from the FDA Transparency Initiative, which Commissioner Margaret A. Hamburg, M.D. launched in 2009. The initiative is designed to examine all agency activities and consider ways to make them more transparent. After holding public meetings and inviting written comments, FDA issued its first report, proposing 21 actions to increase disclosures about agency activities.  Today, the agency is taking sev... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4872884 Thu, 26 May 2011 16:32:37 +0100 4872884 http://www.medworm.com/index.php?rid=4821467&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F05%2F12%2Fupcoming-event-fda-basics-webinar-on-foreign-inspections-may-17-2011-at-1230pm-et%2F Did you know that FDA foreign inspections have doubled since 2008? Did you know that foreign food inspections alone have quadrupled since 2010? As part of FDA Basics, FDA is hosting a webinar on foreign inspections where you can learn more. Susan Laska, the Deputy Director of the Division of Foreign Field Investigations, will give an overview and answer questions about FDA’s Global Inspection program. The free 30 minute webinar will be held Tuesday May 17, 2011 at 12:30 pm ET. There are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA website following the presentation. Learn more about the webinar, including instructions about how to join the webinar. Ann Witt, Transparency Initiative Coordinator (Source: FDA Tr... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4821467 Thu, 12 May 2011 19:55:50 +0100 4821467 http://www.medworm.com/index.php?rid=4754591&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F04%2F26%2Fwhat-needs-fixing-and-how-can-we-fix-it%2F The FDA doesn’t regulate in a vacuum. We need to listen to all our stakeholders – the American people who we protect and the industries we regulate. One important way we do this is by a process called retrospective review of regulations. So what does this mean? As part of a process begun by President Obama, the FDA today announced that we are formally asking for submissions on how to improve existing regulations. Retrospective reviews like this really help us focus on how we can improve our regulations and give us invaluable insights on how we, and those we regulate, can be more innovative and take advantage of innovation as we work to protect and promote the public health. For FDA, review of regulations is grounded in straightforward principles. First, regulations should change wi... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4754591 Tue, 26 Apr 2011 13:13:26 +0100 4754591 http://www.medworm.com/index.php?rid=4735473&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F04%2F20%2Ffda-strategic-priorities-2011-2015%2F Today’s release of a strategic priorities document outlining the goals and strategies that the FDA and its 12,000 employees will pursue through 2015 marks a renewal of our commitment to creating a stronger, more effective agency. Titled “Strategic Priorities 2011 – 2015: Responding to the Public Health Challenges of the 21st Century,” the 50-page document provides a vision of the FDA that includes: a modernized field of regulatory science that draws on innovations in science and technology to help ensure the safety and effectiveness of medical products throughout their life cycles an integrated global food safety system focused on prevention and improved nutrition expanded efforts to meet the needs of special populations. Senior staff from the FDA’s seven product and research c... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4735473 Wed, 20 Apr 2011 16:57:56 +0100 4735473 http://www.medworm.com/index.php?rid=4715131&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F04%2F15%2Fupcoming-event-fda-basics-webinar-by-the-center-for-drug-research-and-evaluation-on-the-bad-ads-program-april-28-2011-at-12-noon-et%2F Did you know that healthcare providers can play an important role in ensuring that prescription drug advertising and promotion is truthful by recognizing and reporting misleading ads? As part of FDA Basics, FDA is hosting a webinar where you can learn more. Catherine Gray, Pharm.D., in the Division of Drug Marketing, Advertising, and Communication (DDMAC) in FDA’s Center for Drug Research and Evaluation will present an overview of the FDA’s “Bad Ad” program, specifically focusing on how to identify misleading prescription drug promotion and report this activity to the agency. The free 30 minute webinar will be held Thursday, April 28 at 12 noon ET. There are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FD... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4715131 Fri, 15 Apr 2011 12:58:12 +0100 4715131 http://www.medworm.com/index.php?rid=4677350&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F04%2F05%2Ffda-launches-consumer-friendly-web-search-for-recalled-products%2F On April 4, 2011, FDA launched a new Web search to make it easier for consumers to search for food and other product recalls. The search results are in the form of a table that organizes information on recalls since 2009, by date, product name, product description, reason for recall, and recalling firm. The table also provides a link to the news release for each recall. This new display of recall information differs from the old display, which provided links in a scroll-down format. Before launching the new search function, FDA consulted with a range of interested stakeholders on how to communicate recall information most effectively. FDA believes the new display of search results will be much easier for consumers to use. Here is a link to the news release announcing the new Web search: ht... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4677350 Tue, 05 Apr 2011 13:40:17 +0100 4677350 http://www.medworm.com/index.php?rid=4654018&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F03%2F29%2Ffda-continues-to-issue-warning-letters-for-illegal-tobacco-sales-to-minors%2F Every day nearly 4,000 kids under 18 try their first cigarette and 1,000 kids under 18 become daily smokers. Virtually all new users of tobacco products are under the minimum legal age to purchase such products. Many of these kids will become addicted before they are old enough to understand the risks and will ultimately die too young of tobacco-related diseases. FDA is working to protect the health of America’s children and ultimately reduce the burden of illness and death caused by tobacco use by enforcing the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents. This regulation, which took effect on June 22, 2010, limits the sale, distributi... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4654018 Tue, 29 Mar 2011 19:20:38 +0100 4654018 http://www.medworm.com/index.php?rid=4571420&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F03%2F10%2Fnew-spanish-language-website-increases-access-to-fda-tobacco-information%2F I am pleased to announce that many portions of FDA’s Center for Tobacco Products (CTP) website are now available in Spanish. This new resource for the Spanish-speaking community will provide key information to our stakeholders in our common goal of reducing the tremendous toll of illness and death from tobacco use through FDA’s new role in tobacco product regulation. By increasing access to our content to the Spanish-speaking public we not only increase the reach of our message, but also make further in-roads into communities that play a key role in tackling this important public health issue. Over the last several months, I’ve heard from many stakeholders in a number of ways about the overall need for CTP to provide key tobacco product information in different languages. This was e... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4571420 Thu, 10 Mar 2011 19:49:03 +0100 4571420 http://www.medworm.com/index.php?rid=4561279&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F03%2F08%2Fmaterials-available-from-fda-basics-webinar-on-fdas-role-in-ensuring-the-safety-of-the-nation%25e2%2580%2599s-blood-supply%2F Did you miss the FDA Basics webinar about FDA’s vital role in ensuring the safety of the nation’s blood supply? You can learn about FDA’s five overlapping layers of blood safety and review rules that are designed to make sure we have a safe and available blood supply, including rules related to donor screening and testing of blood for blood-borne infectious agents. Materials from the webinar are now available. We have posted a link to view and listed to 30 minute webinar and posted a link to download a copy of the presentation slides. You can also find materials from past FDA Basics webinars. (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4561279 Tue, 08 Mar 2011 20:21:21 +0100 4561279 http://www.medworm.com/index.php?rid=4460662&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F02%2F10%2Fdid-you-know-that-fda-plays-a-vital-role-in-ensuring-the-safety-of-the-nation%25e2%2580%2599s-blood-supply%2F As part of FDA Basics, FDA is hosting a webinar where you can learn more FDA’s role in ensuring the safety of the nation’s blood supply.  The featured speaker, Richard Davey, MD, Director of the Division of Blood Applications, Office of Blood Research and Review in FDA’s Center for Biologics Evaluation and Research, will discuss how the agency safeguards the nation’s blood supply and protects the five million people who receive blood transfusions annually. Dr. Davey will provide an overview of these safeguards and will focus on the donor screening process and the testing of blood for blood-borne infectious agents.  After the presentation, there will an opportunity to ask questions. The free 30 minute webinar will be held Tuesday, February 15th, at 2 p.m. ET. There are a l... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4460662 Thu, 10 Feb 2011 17:23:26 +0100 4460662 http://www.medworm.com/index.php?rid=4436986&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F02%2F04%2Fwomens-health-video-blog%2F Today, FDA launched a new video blog that will focus on women’s health issues. The videos for this blog can be found here on the Transparency blog and on the FDA YouTube channel. February 4th is National Wear Red Day which means women across the country will be wearing red to help raise awareness of women’s heart disease. Nearly 43 million women, one-third of all women in America, are living with or are at risk for heart disease.  By some estimates that number could rise significantly by 2030.  Heart disease is also the leading cause of death among women, claiming more lives than chronic obstructive pulmonary disease, diabetes, Alzheimer’s disease, and lung cancer combined. This video is part of our department’s The Heart Truth campaign, which gives women a wakeup call about the... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4436986 Fri, 04 Feb 2011 17:40:38 +0100 4436986 http://www.medworm.com/index.php?rid=4406417&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F01%2F27%2Ffda-posts-first-annual-report-measuring-fdas-success-in-recieving-early-warning-about-problems-with-food-and-animal-feed%2F The Reportable Food Registry (RFR or Registry) is an electronic portal for industry to report when there is a reasonable probability that an article of food will cause serious adverse health consequences.  The Registry helps the FDA better protect public health by tracking patterns and targeting inspections.  The Food and Drug Administration Amendments ACt of 2007 directed FDA to establish a Reportable Food Registry for industry.  The Registry applies to all FDA-regulated categories of food and animal feed (including pet food).  Dietary supplements and infant formula are not included. FDA has posted on the FDA Web site the first annual report that measures the agency’s success in recieving early warning about problems about human food and animal feed.  The report, entitled... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4406417 Thu, 27 Jan 2011 17:35:03 +0100 4406417 http://www.medworm.com/index.php?rid=4372919&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F01%2F19%2Fmaterials-available-from-fda-basics-webinar-on-the-fdas-center-for-tobacco-products-state-enforcement-program%2F Did you miss the FDA Basics webinar about FDA’s Center for Tobacco Products State Enforcement Program?  FDA is contracting with states and U.S. Territories to help with compliance and enforcement activities in order to limit the availablity of tobacco products to young people. Materials from the webinar are now available on the FDA Basics website. Check out the “What’s New” tab on the FDA Basics homepage to download materials from the webinar.  We have posted a link to view and listen to the 30 minute webinar and posted a link to download a copy of the presentation slides. You can find materials from past FDA Basics webinars here. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4372919 Wed, 19 Jan 2011 16:00:05 +0100 4372919 http://www.medworm.com/index.php?rid=4338867&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F01%2F12%2Fnew-updates-on-fda-track-agencys-performance-management-system-2%2F FDA’s performance management system, FDA-TRACK, allows the public to follow the agency’s progress on a range of measures (see April 7 blog  post). New performance data from December 2010  is now available on FDA-TRACK.  Check out FDA-TRACK for updates, including complete FY 2010 data for projects related to human drugs and biological products, and animal drug products. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4338867 Wed, 12 Jan 2011 15:55:46 +0100 4338867 http://www.medworm.com/index.php?rid=4319075&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F01%2F06%2Ffda-launches-web-based-resource-to-make-regulatory-information-more-accessible%2F Today, as part of the third phase of the Transparency Initiative, FDA launched a web-based resource called FDA Basics for Industry to provide basic information about the regulatory process, including information that is frequently requested by industry.   FDA Basics for Industry includes: Easier access to frequently requested content, including, guidance documents, information about the review process, and registration and listing information Links to training modules for industry, such as the Center for Devices and Radiological Health’s CDRH Learn educational tool Answers to questions frequently asked by industry The launch of FDA Basics for Industry is one of the 19 steps outlined in a report issued today by the Transparency Task Force about ways FDA can improve its transparen... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4319075 Thu, 06 Jan 2011 12:04:23 +0100 4319075 http://www.medworm.com/index.php?rid=4310130&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F01%2F05%2Fupcoming-event-fda-basics-webinar-by-the-center-for-tobacco-products-on-the-state-enforcement-program-tuesday-january-11-2011-at-1-pm-et%2F Did you know that the Family Smoking Prevention and Tobacco Control Act gives FDA the authority to contract with states and U.S. Territories to help with compliance and enforcement activities to help limit the availability of tobacco products to young people? As part of FDA Basics, FDA is hosting a webinar where you can learn more.  The featured speaker, Ann Simoneau, Director of the Center for Tobacco Products Office of Compliance and Enforcement, will discuss the state enforcement program for tobacco.  After the presentation, there will be an opportunity to ask questions. The free 30 minute webinar will be held Tuesday, January 11 at 1:00 pm ET. There are a limited number of spots available for the webinar.  Materials from the webinar will also be made available on the FDA Web... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4310130 Wed, 05 Jan 2011 09:25:07 +0100 4310130 http://www.medworm.com/index.php?rid=4281891&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F12%2F22%2Fadditional-information-about-post-approval-studies-conducted-with-medical-devices-now-available%2F FDA is taking steps to improve transparency about studies conducted with devices after approval.   The Center for Devices and Radiological Health (CDRH) has a program that oversees studies that are required as a condition of approving certain applications.  The CDRH Post-Approval Studies (PAS) program helps to ensure that well-designed post approval studies are conducted effectively and efficiently and in the least burdensome manner. CDRH launched a webpage so that the public can keep informed of the progress of each post-approval study.   The webpage displays general information about each post-approval study and now more information is available, including information about the study design, population studied, and data collection methods.  For completed studies, you can fin... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4281891 Wed, 22 Dec 2010 15:17:15 +0100 4281891 http://www.medworm.com/index.php?rid=4266782&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F12%2F15%2Fmonthly-visitor-and-rating-statistics-now-available-on-fda-basics%2F FDA Basics is the agency’s web-based resource that provides basic information to the public about FDA and the work of the agency (see January 12 blog post).  Now available on FDA Basics are summary statistics about the number of visitors coming to the site each month, the number of comments submitted by the public each month,  as well as the average rating (based on a 5 point scale) for the content on FDA Basics.    The statistics will be updated monthly and are available here. Let us know what you think of the new metrics page on FDA Basics.  And continue to check out the content on FDA Basics.  You can suggest additional questions and rank how useful you found the answers we provided.   New content is added on a regular basis (see the “What’s New” ta... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4266782 Wed, 15 Dec 2010 15:27:33 +0100 4266782 http://www.medworm.com/index.php?rid=4246053&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F12%2F09%2Fmaterials-available-from-fda-basics-webinar-on-melamine-the-cause-of-the-pet-food-and-infant-formula-recalls%2F Did you miss the FDA Basics webinar on how FDA uncovered and confirmed the presence of contaminants in the 2007 pet food recalls? Materials from the webinar are now available on the FDA Basics website. Check out the “What’s New” box on the FDA Basics homepage to download materials from the webinar.  We have posted a link to view and listen to the 30 minute webinar and posted a link to download a copy of the presentation slides. You can find materials from past FDA Basics webinars here. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4246053 Thu, 09 Dec 2010 14:26:09 +0100 4246053 http://www.medworm.com/index.php?rid=4233817&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F12%2F06%2Fnew-updates-on-fda-track-agencys-performance-management-system%2F FDA’s performance management system, FDA-TRACK, allows the public to track the agency’s progress on a range of measures, including whether the agency is hitting its inspection targets and whether it is hitting its targets for completing reviews of product applications (see April 7 blog post). New performance data is now available on FDA-TRACK.  Check out FDA-TRACK for updates from November 2010, including updates on the number of Freedom of Information Act (FOIA) requests processed in FY 2010 and the agency’s progress filling vacancies on FDA advisory committees. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4233817 Mon, 06 Dec 2010 14:28:28 +0100 4233817 http://www.medworm.com/index.php?rid=4197621&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F11%2F24%2Fupcoming-event-fda-basics-webinar-on-melamine-the-cause-of-the-pet-food-and-infant-formula-recalls-tuesday-november-30-2010-at-2-pm-et%2F Did you know that FDA regulates that can of cat food, bag of dog food, or box of dog treats or snacks in your pantry? Do you know how FDA uncovered and confirmed the presence of contaminants in the 2007 pet food recalls? As part of FDA Basics, FDA is hosting a webinar where you can learn more.  The featured speaker, Renate Reimschuessel, Research Biologist from the Division of Animal Research, Center for Veterinary Medecine, will discuss how FDA investigated and found contaminants that were imported into the United States and used as ingredients in pet food.  After the presentation, there will be an opportunity to ask questions. The free 30 minute webinar will be held Tuesday, November 30 at 2:00 p.m. ET. There are a limited number of spots available for the webinar.... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4197621 Wed, 24 Nov 2010 14:54:43 +0100 4197621 http://www.medworm.com/index.php?rid=4152516&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F11%2F10%2Fhelp-reduce-the-health-burden-of-tobacco-use-in-america%25e2%2580%2594comment-on-the-new-proposed-graphic-health-warning-labels-for-cigarette-packs-and-advertisements%2F Cigarette smoking kills an estimated 443,000 Americans each year, most of whom began smoking when they were under the age of 18. Tobacco use is the foremost preventable cause of premature death in America, and has been shown to cause cancer, heart disease, and other serious adverse health effects. Nearly 50,000 deaths annually are attributed to non-smokers’ exposure to secondhand smoke. That’s why today, we took another important step to protect the health of the American public from the toll of disease, disability and death caused by tobacco use in this county. Earlier this morning, I joined Secretary of Health and Human Services Kathleen Sebelius, Assistant Secretary for Health Dr. Howard Koh and FDA Commissioner Margaret A. Hamburg to announce a proposal to require ne... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4152516 Wed, 10 Nov 2010 18:43:27 +0100 4152516 http://www.medworm.com/index.php?rid=4135141&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F11%2F04%2Fmaterials-available-from-fda-basics-webinar-on-the-food-emergency-response-network-fern%2F Did you miss the FDA Basics webinar on the Food Emergency Response Network (FERN)?  FERN is an organization of the nation’s regulatory food testing laboratories whose purpose is to detect, identify, respond to and recover from bioterrorism or public health emergencies involving our food supply. Materials from the webinar are now available on the FDA Basics website. Check out the “What’s New” box on the FDA Basics homepage to download materials from the webinar.  We have posted a link to view and listen to the 30 minute webinar and posted a link to download a copy of the presentation slides. You can find materials from past FDA Basics webinars here. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4135141 Thu, 04 Nov 2010 18:34:20 +0100 4135141 http://www.medworm.com/index.php?rid=4109344&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F10%2F27%2Ffda-basics-video-available-about-drug-development-for-minor-use-in-major-species-and-for-use-in-minor-species%2F As part of FDA Basics, FDA has posted a video with Dr. Margaret Oeller, director of  FDA’s Office of Minor Use and Minor Species Animal Drug Development in the Center for Veterinary Medicine.  Dr. Oeller discusses FDA’s role in encouraging drug development for specific ”minor uses” in major species and for specific diseases affecting  “minor species,” which include zoo animals, honeybees, game birds, and aquaculture.  There are only seven major species; all other species are considered “minor species.”  View the video below. (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4109344 Wed, 27 Oct 2010 15:11:09 +0100 4109344 http://www.medworm.com/index.php?rid=4089076&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F10%2F20%2Fupcoming-event-fda-basics-webinar-on-the-food-emergency-response-network-fern-tuesday-october-26th-100-p-m-et%2F Did you know that there is an organization of the nation’s regulatory food testing laboratories whose purpose is to detect, identify, respond to and recover from bioterrorism or public health emergencies involving our food supply? As part of FDA Basics, FDA is hosting a webinar where you can learn more.  The featured speaker, Carl Sciacchitano, Director of the Division of Field Science in FDA’s Office of Regulatory Affairs (ORA), will describe the Food Emergency Response Network (FERN) and its role in protecting the nation’s food supply.  After the presentation, there will be an opportunity to ask questions. The free 30 minute webinar will be held on Tuesday, October 26, at 1:00 p.m. ET. There are a limited number of spots available for the webinar.  ... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4089076 Wed, 20 Oct 2010 15:02:57 +0100 4089076 http://www.medworm.com/index.php?rid=4061963&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F10%2F13%2Fnew-fda-basics-video-available-about-the-effective-and-proper-uses-of-medicines-and-devices-in-children%2F As part of FDA Basics, FDA has posted a video with Dr. Dianne Murphy, director of FDA’s Office of Pediatric Therapeutics.  Dr. Murphy discusses how FDA helps to develop knowledge about the proper and effective use of drugs and devices in children.  View the video below. (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4061963 Wed, 13 Oct 2010 10:26:29 +0100 4061963 http://www.medworm.com/index.php?rid=4061964&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F10%2F07%2Fmaterials-available-from-fda-basics-webinar-on-%25e2%2580%259cgeneric-drugs%2F Did you miss the FDA Basics webinar about generic drugs? Materials from the webinar are now available on the FDA Basics website. Check out the “What’s New” box on the FDA Basics homepage to download materials from the webinar.  We have posted a link to view and listen to the 30 minute webinar and posted a link to download a copy of the presentation slides. ** There were audio difficulties during the first couple of minutes of the 30 minute webinar.** You can find materials from past FDA Basics webinars here. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4061964 Thu, 07 Oct 2010 08:00:43 +0100 4061964 http://www.medworm.com/index.php?rid=4037358&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F10%2F07%2Fmaterials-available-from-fda-basics-webinar-on-%25e2%2580%259cgeneric-drugs%2F Did you miss the FDA Basics webinar about generic drugs? Materials from the webinar are now available on the FDA Basics website. Check out the “What’s New” box on the FDA Basics homepage to download materials from the webinar.  We have posted a link to view and listen to the 30 minute webinar and posted a link to download a copy of the presentation slides. ** There were audio difficulties during the first couple of minutes of the 30 minute webinar.** You can find materials from past FDA Basics webinars here. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4037358 Thu, 07 Oct 2010 08:00:43 +0100 4037358 http://www.medworm.com/index.php?rid=4032252&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F10%2F05%2Ffda-information-is-now-on-facebook-and-flickr%2F FDA has a new Facebook page at: www.facebook.com/fda The page provides regular updates on FDA news and events as well as federal health safety information of interest to the public.  Share this information with your Facebook friends and leave us posts letting us know what you would like to see. FDA is also taking its public health message to Flickr.  You can see pictures of FDA scientists and investigators working to protect and promote the public health, and more.  Visit FDA’s Flickr photostream and let us know what you think.  Afia Asamoah, Transparency Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4032252 Tue, 05 Oct 2010 08:00:02 +0100 4032252 http://www.medworm.com/index.php?rid=4019054&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F10%2F01%2Ffdas-center-for-devices-and-radiological-health-cdrh-launches-inspections-database%2F Yesterday, as part of the FDA Transparency Initiative, CDRH launched the ‘CDRH Inspections Database’.  The database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present (approximately 25% of the medical device inspections conducted since 2008).  The database contains information about the firms, types of devices and inspections, and links to warning letters (when available). You can search the inspection database by various parameters, including company name, inspection type, product code, inspection classifaction, inspection action, and date.  You can find the database here. We encourage your feedback on the database and welcome your suggestions for additional information you would like to see.  You can provide f... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4019054 Fri, 01 Oct 2010 08:00:22 +0100 4019054 http://www.medworm.com/index.php?rid=4019055&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F09%2F30%2Fas-part-of-the-open-government-data-initiativethe-fdahas-created-a-new-section-foragency-data-setson-fdagov-the-new-sectio%2F As part of making data available through the Department of Health and Human Services (HHS) Open Government Initiative, FDA has created a new section of the FDA Web site for agency data sets. The new section includes all available downloadable data for major recalls from 2009 to present based on information provided by firms in press releases, including data on the recent Shell Egg recall.  The new gateway features data sets in XML format, which allows developers to easily create applications and mashups centered around FDA data.     You can check out the data sets here.  Let us know what you think by leaving a comment on this blog or sending an email to webmail@oc.fda.gov, subject line “FDA Data Gateway Feedback.”  As we look ahead, we are interested in your ideas ... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4019055 Thu, 30 Sep 2010 09:00:45 +0100 4019055 http://www.medworm.com/index.php?rid=3988927&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F09%2F22%2Fmaterials-available-from-fda-public-webinar-about-the-%25e2%2580%259c510k-premarket-review-process%25e2%2580%259d-and-the-%25e2%2580%259cuse-of-science-in-regulatory-decision-making%25e2%2580%259d-draft-reports%2F Did you miss the FDA webinar discussion on the draft reports about the 510(k) process and the use of science in regulatory decisions?   The webinar was discussed in a August 26, 2010 blog post.  Materials from the webinar are now available on the CDRH website.  You can listen to the discussion here.  FDA is soliciting comments from the public on the draft reports via www.regulations.gov, docket number FDA-2010-N-0348, until October 4, 2010. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3988927 Wed, 22 Sep 2010 16:29:40 +0100 3988927 http://www.medworm.com/index.php?rid=4061965&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F09%2F20%2Fbasics-webinar-generic-drugs%2F Did you know that generic drugs are safe and effective alternatives to brand name drugs? Did you know that generic drugs can reduce the cost of prescription drugs for both consumers and the government? As part of FDA Basics, FDA is hosting a webinar where you can learn more. The featured speaker Robert West, a supervisory pharmacist in the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research (CDER), will give an overview of generic drug regulation.  After the presentation, there will be an opportunity to ask questions. The free 30 minute webinar will be held on Monday, September 27, at 1:00 p.m. ET. Sign in early, since there are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA Web site. Click ... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4061965 Mon, 20 Sep 2010 21:22:23 +0100 4061965 http://www.medworm.com/index.php?rid=3988928&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F09%2F20%2Fbasics-webinar-generic-drugs%2F Did you know that generic drugs are safe and effective alternatives to brand name drugs? Did you know that generic drugs can reduce the cost of prescription drugs for both consumers and the government? As part of FDA Basics, FDA is hosting a webinar where you can learn more. The featured speaker Robert West, a supervisory pharmacist in the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research (CDER), will give an overview of generic drug regulation.  After the presentation, there will be an opportunity to ask questions. The free 30 minute webinar will be held on Monday, September 27, at 1:00 p.m. ET. Sign in early, since there are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA Web site. Click ... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3988928 Mon, 20 Sep 2010 21:22:23 +0100 3988928 http://www.medworm.com/index.php?rid=4061966&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F09%2F20%2Fnew-fda-basics-main-page%2F It’s been almost 9 months since the FDA Basics section of the FDA website launched. After collecting web traffic data during this time, we decided to make some minor changes to the main page in hopes of improving your experience. The changes include: Cleaner look-and-feel Easier access to the major content areas, videos, and webinars Restructured slideshow The newly redesigned FDA Basic main page will launch later this month. In the meantime, see below for images of the current main page (1st picture) and the new main page (2nd picture). Click the images below to see the full size image. Current FDA Basics Main Page New FDA Basics Main Page Post a comment below to let us know what you think. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4061966 Mon, 20 Sep 2010 14:36:35 +0100 4061966 http://www.medworm.com/index.php?rid=3984176&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F09%2F20%2Fnew-fda-basics-main-page%2F It’s been almost 9 months since the FDA Basics section of the FDA website launched. After collecting web traffic data during this time, we decided to make some minor changes to the main page in hopes of improving your experience. The changes include: Cleaner look-and-feel Easier access to the major content areas, videos, and webinars Restructured slideshow The newly redesigned FDA Basic main page will launch later this month. In the meantime, see below for images of the current main page (1st picture) and the new main page (2nd picture). Click the images below to see the full size image. Current FDA Basics Main Page New FDA Basics Main Page Post a comment below to let us know what you think. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3984176 Mon, 20 Sep 2010 14:36:35 +0100 3984176 http://www.medworm.com/index.php?rid=3970048&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F09%2Fcoming-soon-new-look-to-the-fda-transparency-blog.html You may notice some changes and a few new features on the FDA Transparency Blog soon.  FDA is planning to move the blog to a new hosting platform in the next few weeks.  After the move, you will be able to tag blog posts with a 1-5 'star' rating and easily view the top rated posts with a single click.  In addition, you will be able to easily print and share posts via email in the form of new buttons at the bottom of each blog post. We also plan to add similar buttons that will allow you to share posts with your friends on popular social networking sites like Twitter and Facebook. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3970048 Wed, 15 Sep 2010 13:00:00 +0100 3970048 http://www.medworm.com/index.php?rid=3921760&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F09%2Ffdatrack-stay-informed-on-agencywide-program-performance-by-subscribing-to-fdatrack-web-updates.html In April, FDA launched a web resource called FDA-TRACK that allows the public to track the agency's progress on a range of measures, including whether the agency is hitting its inspection targets and whether it is hitting its targets for completing reviews of product applications (see April 7 blog post). Now, you can receive free email notifications when measures tracked on FDA-TRACK are updated by subscribing to "FDA-TRACK Updates."  "FDA-TRACK Updates" will send you an email alerting you when the performance data on FDA-TRACK are updated.  The subscription will allow you to choose how often you would like to recieve updates.  You can cancel at any time. Thank you for your feedback thus far. We are working to i... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3921760 Wed, 01 Sep 2010 12:00:00 +0100 3921760 http://www.medworm.com/index.php?rid=3904397&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F08%2Fupcoming-event-fda-public-webinar-about-the-510k-premarket-review-process-and-the-use-of-science-in-.html FDA recently published two preliminary reports conducted by the Center for Devices and Radiological Health (CDRH).  The first preliminary report is an assessment of the process used to review certain medical device applications before they are marketed (known as the 510(k) process) and draft recommendations.  The second preliminary report is an assessment of the use of science in CDRH's regulatory decision making and draft recommendations.  This is the first step in determining what, if any, improvements to these processes FDA may implement. Next week, FDA is hosting a webinar where CDRH officials will discuss the details of both reports.  There will be an opportunity to ask questions. The&#... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3904397 Thu, 26 Aug 2010 12:00:00 +0100 3904397 http://www.medworm.com/index.php?rid=3977716&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F08%2F26%2Fupcoming-event-fda-public-webinar-about-the-510k-premarket-review-process-and-the-use-of-science-in%2F FDA recently published two preliminary reports conducted by the Center for Devices and Radiological Health (CDRH).  The first preliminary report is an assessment of the process used to review certain medical device applications before they are marketed (known as the 510(k) process) and draft recommendations.  The second preliminary report is an assessment of the use of science in CDRH's regulatory decision making and draft recommendations.  This is the first step in determining what, if any, improvements to these processes FDA may implement. Next week, FDA is hosting a webinar where CDRH officials will discuss the details of both reports.  There will be an opportunity to ask questions. The live webina... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3977716 Thu, 26 Aug 2010 08:00:00 +0100 3977716 http://www.medworm.com/index.php?rid=3896835&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F08%2Ffind-out-more-about-fda-new-questions-and-answers-available-on-fda-basics.html Have you seen the term "FDA Advisory Committees" and wondered what they are and what they do? Last week, FDA added six new questions about the advisory committee process to FDA Basics, the web-based resource that provides information about FDA and what the agency does.  The questions include: What is an FDA Advisory Committee? How does an individual become a member of an FDA advisory committee? What are the qualifications of a scientific member of an advisory committee? How does the FDA use Advisory Committees to make decisions about drugs? Find out answers to these questions and more in the "FDA Fundamentals" section of FDA Basics!  You can also rate how helpful the answer was.  We use this feedback to improve the answers and add more que... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3896835 Tue, 24 Aug 2010 12:00:00 +0100 3896835 http://www.medworm.com/index.php?rid=3877895&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F08%2Fmaterials-available-from-fda-basics-webinar-on-.html Did you miss the FDA Basics webinar about how to use a food label to make smart food choices? Materials from the webinar are now available on the FDA Basics website. Check out the "What's New" box on the FDA Basics homepage to download materials from the webinar.  We have posted a link to view and listen to the 30 minute webinar and posted a link to download a copy of the presentation slides. You can find materials from past FDA Basics webinars here. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3877895 Wed, 18 Aug 2010 12:00:00 +0100 3877895 http://www.medworm.com/index.php?rid=3977718&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F08%2F18%2Fmaterials-available-from-fda-basics-webinar-on%2F Did you miss the FDA Basics webinar about how to use a food label to make smart food choices? Materials from the webinar are now available on the FDA Basics website. Check out the "What's New" box on the FDA Basics homepage to download materials from the webinar.  We have posted a link to view and listen to the 30 minute webinar and posted a link to download a copy of the presentation slides. You can find materials from past FDA Basics webinars here. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3977718 Wed, 18 Aug 2010 08:00:00 +0100 3977718 http://www.medworm.com/index.php?rid=3855895&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F08%2Fwhat-is-fdatrack.html FDA has posted a video explaining FDA-TRACK, the performance management system the agency launched in April (see April 7 blog post).   FDA-TRACK is a web resource that provides information about the breadth of FDA's activities to promote and protect the public health.   The video features FDA Principal Deputy Commissioner, Dr. Joshua Sharfstein and FDA Center Directors Drs. Bernadette Dunham and Janet Woodcock.  View the video below, then check out the information currently available on FDA-TRACK about FDA's progress on a range of activities and let us know what you think. (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3855895 Wed, 11 Aug 2010 19:31:56 +0100 3855895 http://www.medworm.com/index.php?rid=3817955&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F08%2Fupcoming-events-fda-basics-webinar-on-using-a-food-label-to-make-smart-food-choices-tuesday-august-1.html What is "% DV" found on food labels and why is it important? What’s the relationship between serving size and total calories?  As part of FDA Basics, FDA is hosting a webinar where you can learn more. The featured speaker, Essie Yamini, a nutritionist and a Registered Dietitian with a Ph.D. in nutritional biochemistry, works with the science review team at FDA’s Center for Food Safety and Applied Nutrition. Dr. Yamini will give an overview and answer questions about the Nutrition Facts Label.  After the presentation there will be an opportunity to ask questions. The free 30 minute webinar will be held on Tuesday, August 10, at 1:30 p.m. ET. Sign in early, since there are a limited number of spots available fo... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3817955 Wed, 04 Aug 2010 16:40:36 +0100 3817955 http://www.medworm.com/index.php?rid=3795998&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F07%2Fbased-oncomments-from-the-public-fda-has-added-7-new-questions-to-fda-basics-the-web-based-resource-that-provides-informa.html Based on comments from the public, FDA has added 7 new questions to FDA Basics, the web-based resource that provides information about FDA and what the agency does.  Below is a sample of some of the new questions about FDA and the work we do. When and why was FDA formed? How do I report a bad reaction to medicne or medication error to FDA? What is a 'recall'? Is FDA responsible for regulating pesticides that are used in animal products? Find out answers to these questions and more at FDA Basics!   Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3795998 Wed, 28 Jul 2010 13:32:33 +0100 3795998 http://www.medworm.com/index.php?rid=3777752&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F07%2Fmaterials-available-from-fda-basics-webinar-on-fdas-safety-monitoring-of-approved-vaccines.html Did you miss the FDA Basics webinar about how FDA reviews vaccine safety after a  vaccine is approved? Do you know why it is important to have different types of systems to perform safety surveillance for approved vaccines? Check out the "What’s New" box on the FDA Basics home page to download materials from the webinar. We have posted a link to view and listen to the 30 minute webinar as well posted a link to download a copy of the presentation slides. You can find materials from past FDA Basics webinars here. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3777752 Thu, 22 Jul 2010 13:00:00 +0100 3777752 http://www.medworm.com/index.php?rid=3977722&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F07%2F22%2Fmaterials-available-from-fda-basics-webinar-on-fdas-safety-monitoring-of-approved-vaccines%2F Did you miss the FDA Basics webinar about how FDA reviews vaccine safety after a  vaccine is approved? Do you know why it is important to have different types of systems to perform safety surveillance for approved vaccines? Check out the "What’s New" box on the FDA Basics home page to download materials from the webinar. We have posted a link to view and listen to the 30 minute webinar as well as posted a link to download a copy of the presentation slides. You can find materials from past FDA Basics webinars here. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3977722 Thu, 22 Jul 2010 10:00:00 +0100 3977722 http://www.medworm.com/index.php?rid=3768234&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F07%2Fnew-fda-basics-video-available-about-fdas-regulation-of-tobacco-products.html As part of FDA Basics, FDA has posted a new video with Dr. Lawrence Deyton, director of FDA's Center for Tobacco Products.  Dr. Deyton discusses FDA's new authority to regulate tobacco products.  View the video below. (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3768234 Tue, 20 Jul 2010 13:00:00 +0100 3768234 http://www.medworm.com/index.php?rid=3977723&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F07%2F20%2Fnew-fda-basics-video-available-about-fdas-regulation-of-tobacco-products%2F As part of FDA Basics, FDA has posted a new video with Dr. Lawrence Deyton, director of FDA's Center for Tobacco Products.  Dr. Deyton discusses FDA's new authority to regulate tobacco products.  View the video below. (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3977723 Tue, 20 Jul 2010 09:00:00 +0100 3977723 http://www.medworm.com/index.php?rid=3759286&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F07%2Fwe-want-your-feedback-public-comment-period-ends-july-20-feature-topic-4-docket-management-process.html On May 19, the Transparency Task Force released 21 draft proposals about information FDA should consider making available to the public. (see previous blog post). The time to provide the Task Force with your feedback on these draft proposals ends Tuesday, July 20. The fourth topic being featured for your input is the Docket Management Process.  The draft proposal for public comment is about the following issue: Whether FDA should change its current practice so that comments submitted to www.regulations.gov from people self-identified as individual consumers are posted to that Web site in the same manner as other comments. Click here to comment on and rate the proposal.  You can read the draft proposal, FDA's reason for the proposa... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3759286 Fri, 16 Jul 2010 14:42:24 +0100 3759286 http://www.medworm.com/index.php?rid=3755102&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F07%2Fwe-want-your-feedback-public-comment-period-ends-july-20-feature-topic-3-product-applications.html On May 19, the Transparency Task Force released 21 draft proposals about information FDA should consider making available to the public. (see previous blog post). The time to provide the Task Force with your feedback on these draft proposals ends next Tuesday, July 20. The second topic being featured for your input is Product Applications.  For example, some of the draft proposals for comment would allow FDA to: Better explain FDA decisions -- One proposal for comment is to allow FDA to explain when the agency declines to approve medical products.   Click here to comment on and rate the proposal.  You can read the draft proposal, FDA's reason for the proposal, and other comments submitted so far. Provide more data to doctors and p... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3755102 Thu, 15 Jul 2010 13:43:54 +0100 3755102 http://www.medworm.com/index.php?rid=3747618&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F07%2Fwe-want-your-feedback-public-comment-period-ends-next-week-feature-topic-2-recalls.html On May 19, the Transparency Task Force released 21 draft proposals about information FDA should consider making available to the public. (see previous blog post). The time to provide the Task Force with your feedback on these draft proposals ends next Tuesday, July 20. The second topic being featured for your input is Recalls.  The draft proposals are about the following issues: When a system is set up that provides FDA with the authority to require companies to submit certain information about recalled products to FDA, disclosing this information after FDA recieves it from the firm.   Click here to comment on and rate the proposal.  You can read the draft proposal, FDA's reason for the proposal, and other comments subm... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3747618 Tue, 13 Jul 2010 16:09:19 +0100 3747618 http://www.medworm.com/index.php?rid=3744475&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F07%2Fwe-want-your-feedback-on-fdas-disclosure-policy-public-comment-period-ends-next-week.html On May 19, FDA released 21 draft proposals about information FDA should consider making available to the public. (see previous blog post). The time to provide FDA with your feedback on these draft proposals ends next Tuesday, July 20.   Over the next week, we will feature some of the draft proposals on this Blog in order to get your feedback.  The first topic being featured is FDA inspections.    ·     FDA proposes to disclose certain information about the inspections it conducts.  Click here to comment on and rate the proposal.  You can read the draft proposal, FDA's reason for the proposal, and other comments submitted so far. ·     FDA proposes to share with the public information a... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3744475 Mon, 12 Jul 2010 19:12:17 +0100 3744475 http://www.medworm.com/index.php?rid=3734513&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F07%2Fupcoming-event-fda-basics-webinar-on-fdas-safety-monitoring-of-approved-vaccines-tuesday-july-13-2-p.html Did you know that FDA’s review of vaccine safety doesn’t stop once a vaccine is approved?  Why is it important to have different types of systems to perform safety surveillance for approved vaccines? As part of FDA Basics, FDA is hosting a webinar where you can learn more.  The featured speaker, Andrea Sutherland, MD, MPH, Msc, a medical officer in the Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, will give an overview about vaccine safety surveillance, including the Vaccine Adverse Event Reporting System (or VAERS), and efforts underway to improve safety monitoring.  After the presentation, there will an opportunity to ask questions. The free 30 minute webinar will be held on Tuesday, July 13, at 2 p.m. ET. ... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3734513 Thu, 08 Jul 2010 21:22:46 +0100 3734513 http://www.medworm.com/index.php?rid=3727519&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F07%2Fmaterials-available-from-fda-basics-webinar-on-fdas-regulation-of-tobacco-products-the-year-in-revie.html Did you miss the FDA Basics webinar on "FDA's Regulation of Tobacco Products"? Check out the “What’s New” box on the FDA Basics home page to download materials from the webinar.  We have posted a link to listen to the entire 30 minute webinar as well posted a link to download a copy of the presentation slides.   You can find materials from past FDA Basics webinars here.   Afia Asamoah Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3727519 Tue, 06 Jul 2010 13:01:57 +0100 3727519 http://www.medworm.com/index.php?rid=3692175&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F06%2Fupcoming-events-fda-basics-webinar-on-fdas-regulation-of-tobacco-products-the-year-in-review-and-loo.html Did you know that FDA was given the authority to regulate tobacco products last year? Do you want to learn about steps FDA has taken since that time? As part of FDA Basics, FDA is hosting a webinar where you can learn more. The featured speaker, Lawrence R. Deyton, M.S.P.H., M.D., Director, Center for Tobacco Products, will discuss several important steps FDA is taking in a coordinated effort to prevent our children from becoming the next generation of Americans to die prematurely from tobacco use and ultimately reducing death and disease associated with tobacco use. After the presentation there will be an opportunity to ask questions. The free 30 minute webinar will be held on Tuesday, June 29, at 11 a.m. ET. Sign in early, since there are a limited number of spots available for the webi... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3692175 Thu, 24 Jun 2010 15:01:43 +0100 3692175 http://www.medworm.com/index.php?rid=3680777&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F06%2Fnew-fda-basics-video-available-about-orphan-drugs-and-the-fight-against-rare-diseases.html As part of FDA Basics, FDA has posted a new video with Dr. Tim Cote, director of FDA's Office of Orphan Products Development.  Dr. Cote discusses how FDA's Orphan Drugs program helps in the fight against rare diseases.  View the video below. (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3680777 Mon, 21 Jun 2010 13:00:00 +0100 3680777 http://www.medworm.com/index.php?rid=3667448&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F06%2Ffda-launches-webpage-with-summaries-of-safety-data-on-new-drugs.html On Tuesday, June 15, FDA launched a web page where you can find summaries of safety information about recently approved drugs and a brief discussion of any steps FDA may be taking to address any identified safety issues. New drugs approved after September 27, 2007 will receive a safety summary within roughly two years of approval. The summaries address safety risks that were not identified during a drug's development or prior to FDA approval. FDA plans to publish summaries on a quarterly basis. The first set of safety summaries for 26 products approved in 2008 can be found here. You can find questions and answers about FDA's plan to post safety summaries here. Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3667448 Thu, 17 Jun 2010 14:00:00 +0100 3667448 http://www.medworm.com/index.php?rid=3663627&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F06%2Ffind-out-more-about-fda-new-questions-and-answers-available-on-fda-basics.html In May, based on comments from the public, FDA added 12 new questions to FDA Basics, the web-based resource that provides information about FDA and what the agency does. Have you wondered how many people work at FDA? Do you know what to do with medicine you no longer need? Do you know if FDA has a definition for the term "organic" on food labels? Find out answers to these questions, and more at FDA Basics!   Afia Asamoah, Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3663627 Tue, 15 Jun 2010 18:39:26 +0100 3663627 http://www.medworm.com/index.php?rid=3608506&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F05%2Fmaterials-available-from-fda-basics-webinar-on-indoor-tanning-risks-of-uv-radiation.html Did you miss the FDA Basics webinar on “Indoor Tanning: Risks of UV Radiation”?   Check out the “What’s New” box on the FDA Basics home page to download materials from the webinar.  We have posted a link to listen to the entire 30 minute webinar as well as a copy of the presentation slides.   You can find materials from past FDA Basics webinars here.   Afia Asamoah Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3608506 Fri, 28 May 2010 13:33:38 +0100 3608506 http://www.medworm.com/index.php?rid=3608507&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F05%2Fmaterials-available-from-fda-basics-webinar-on-safeguarding-the-us-food-supply-excellent-industry-co.html Did you miss the FDA Basics webinar on Safeguarding the U.S. Food Supply, Excellent Industry Compliance with the Final Bovine Spongiform Encephalopathy (BSE) Rule? Check out the "What's New" box on the FDA Basics home page to download materials from the webinar. There, you will find a link to listen to the entire 30 minute webinar and you can download a copy of the presentation slides. Afia Asamoah, Transparency Initiaitve Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3608507 Fri, 28 May 2010 13:21:13 +0100 3608507 http://www.medworm.com/index.php?rid=3592954&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F05%2Fupcoming-events-fda-basics-webinar-on-indoor-tanning-risks-of-uv-radiation-wednesday-may-26-2-pm-et.html Do you have questions about Indoor Tanning? Did you know that FDA regulates tanning beds? As part of FDA Basics, FDA is hosting a webinar where you can learn more.  Featured speakers, Sharon Miller, M.S.E.E., FDA Ultraviolet Radiation Expert and Varsha Savalia, M.P.H, FDA Tanning Products Compliance Officer from the Division of Mammography Quality and Radiation Programs, Center for Devices and Radiological Health, will explain what UV radiation is, discuss the risks of UV radiation, and describe steps to reduce the risks associated with the use of tanning beds. After the presentation, there will be an opportunity to ask questions. The free 30 minute webinar will be held on Wednesday, May 26, at 2 p.m. ET. There are a limited number of spots available for the webinar.&#016... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3592954 Mon, 24 May 2010 17:08:40 +0100 3592954 http://www.medworm.com/index.php?rid=3578681&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F05%2Ffda-unveils-draft-proposals-on-agency-disclosure-policies-for-public-comment.html Today, as part of the second phase of the Transparency Initiative, the Transparency Task Force released 21 draft proposals about FDA’s disclosure policies.  FDA is asking for comments on the proposals for 60 days.  After 60 days, FDA will use your input to recommend specific proposals to FDA Commissioner Dr. Margaret Hamburg for implementation.  You can read more about the transparency report FDA is releasing today in a Perspective article in the New England Journal of Medicine online, “Transparency at the U.S. Food and Drug Administration.” FDA will not necessarily implement each of these ideas.  Some of the proposals require extensive resources to implement and some may require changes to regulations or legislation.  Visit the FDA Web site to read th... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3578681 Wed, 19 May 2010 13:39:34 +0100 3578681 http://www.medworm.com/index.php?rid=3516383&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F04%2Fmaterials-available-from-fda-basics-webinar-on-safeguarding-the-us-food-supply-excellent-industry-co.html Did you miss the FDA Basics webinar on Safeguarding the U.S. Food Supply, Excellent Industry Compliance with the Final Bovine Spongiform Encephalopathy (BSE) Rule? Check out the "What's New" box on the FDA Basics home page to download materials from the webinar. There, you will find a link to listen to the entire 30 minute webinar and you can download a copy of the presentation slides. Afia Asamoah, Transparency Initiaitve Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3516383 Thu, 29 Apr 2010 14:54:08 +0100 3516383 http://www.medworm.com/index.php?rid=3487902&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F04%2Fupcoming-events-fda-basics-webinar-on-safeguarding-the-us-food-supply-excellent-industry-compliance-.html Did you know that FDA works to keep the food supply in the U.S. safe for people and animals? Everyday, FDA is protecting people by making sure that the food they eat comes from healthy animals.  As part of FDA Basics, FDA is hosting a webinar where you can learn more.  Featured speakers Shannon Jordre, Consumer Safety Officer and Burt Pritchett, Veterinary Medical Officer from the Division of Compliance, Center for Veterinary Medicine, will discuss animal feed controls FDA has put in place to keep BSE out of the U.S. cattle population, thereby ensuring the safety of the nation's food supply from BSE.  After the presentation, there will be a chance to ask questions. The free 30 minute webinar will be held on Thursday, April 22, at 2 p.m. ET. You can find out more... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3487902 Tue, 20 Apr 2010 18:11:37 +0100 3487902 http://www.medworm.com/index.php?rid=3483617&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F04%2Ffda-launches-medical-device-and-radiationemitting-product-transparency-web-site-.html Today, the U.S. Food and Drug Administration (FDA) launched the Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative.  This site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data to support those decisions. The new Web site is part of an ongoing effort within FDA to enhance communication and transparency.  This Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format.  The site includes new information such as:   · basic information about medical devices and how FDA regulates those products · information about medical devi... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3483617 Mon, 19 Apr 2010 15:13:59 +0100 3483617 http://www.medworm.com/index.php?rid=3444799&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F04%2Ffda-launches-fdatrack-to-make-more-information-about-the-work-of-fdas-program-offices-available.html Today, FDA launched a new website that will help the public understand the breadth of FDA's core responsibilities to promote and protect the public health.  The website is called FDA-TRACK: Agency-wide Program Performance.  FDA-TRACK is FDA's new agency-wide performance management and accountability tool.  The FDA-TRACK website will allow you to gain insights about: Each of our program offices and what they do Each program office's key performance goals and projects On a quarterly basis, each FDA program office will submit monthly performance data and present that information to FDA senior leadership. This information will be posted on the FDA-TRACK website and the public can track this information and monitor the accomplishments ... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3444799 Wed, 07 Apr 2010 17:30:00 +0100 3444799 http://www.medworm.com/index.php?rid=3433790&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F04%2Ftransparency-to-regulated-industry-communicating-with-sponsors-during-fdas-review-of-the-product-app.html The Task Force is collecting information on how to improve FDA's transparency to regulated industry.  We held three listening sesions with members of regulated industry on January 21, 27, and 28.  Transcripts and summaries of those listening sessions are available online and we are seeking comments from the public on the issues raised in those sessions, or other suggestions related to FDA's transparency to regulated industry.  Our next question is: What information, if any, should FDA provide to sponsors during the agency's review of the sponsor's product application? We look forward to your ideas. Transparency Task Force (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3433790 Fri, 02 Apr 2010 14:21:10 +0100 3433790 http://www.medworm.com/index.php?rid=3409247&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F03%2Ftransparency-to-regulated-industry-how-can-fda-improve-its-guidance-development-process.html The Task Force is collecting information on how to improve FDA's transparency to regulated industry.  We held three listening sesions with members of regulated industry on January 21, 27, and 28.  Transcripts and summaries of those listening sessions are available online and we are seeking comments from the public on the issues raised in those sessions, or other suggestions related to FDA's transparency to regulated industry.  Our next question is: What changes, if any, should FDA make to its guidance development process? We look forward to your ideas. Transparency Task Force (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3409247 Fri, 26 Mar 2010 14:04:20 +0100 3409247 http://www.medworm.com/index.php?rid=3391495&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F03%2Fupcoming-events-fda-basics-webinar-on-the-inspection-process-march-25-2-pm-et.html What kinds of products and facilities does the Food and Drug Administration (FDA) inspect? Who conducts these inspections?  What do they look for?   As part of FDA Basics, FDA is hosting a webinar where you can learn more about FDA’s inspection process.  The featured speaker, Michael Rogers, Deputy Director, Office of Regional Operations, will discuss how FDA staff inspect domestic and foreign establishments, check shipments of imported product, and collect and test samples for signs of contamination.  There will be time for questions following the presentation. The free 30 minute webinar will be held on Thursday, March 25, at 2 p.m. ET. You can find out more information about the webinar, including how to participate in the webinar on the FDA Basics homepa... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3391495 Mon, 22 Mar 2010 14:00:00 +0100 3391495 http://www.medworm.com/index.php?rid=3375377&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F03%2Fagency-posts-review-documents-for-some-popular-prescription-drugs-.html FDA has posted on its website information from the agency’s review of 8 of the most prescribed brand name drugs that were approved before 1998.    The posted records are from the agency’s historical file of information that was previously disclosed under the Freedom of Information Act.  The records are posted as is and have not been previously posted due to the quality of some of the records.  The best available copies have been posted.   Approval information for the following drugs is now available on the FDA website: Diovan Flomax Klor-Con Lipitor Nasonex Plavix Prevacid Tricor This information can be found online by searching for the drug name.   Afia Asamoah Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3375377 Wed, 17 Mar 2010 21:19:35 +0100 3375377 http://www.medworm.com/index.php?rid=3360220&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F03%2Ffinal-phase-of-the-transparency-initiative-we-want-your-ideas.html As part of the final phase of the Transparency Initiative, we are looking for ideas from the public on how FDA can increase transparency with regulated industry, in order to foster a more effective and efficient regulatory process.  These comments will be used to inform draft recommendations the Task Force will put forward this spring on ways FDA may improve transparency to regulated industry.   FDA regulates products responsible for about 25 percent of the gross national product of the United States and the industries responsible for these products. Products regulated by the agency – biologics and blood products, human drugs, foods, medical devices, radiation-emitting devices, and veterinary medicines – are integral to public health and to the U.S. economy.   T... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3360220 Fri, 12 Mar 2010 17:18:47 +0100 3360220 http://www.medworm.com/index.php?rid=3323618&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F03%2Fmaterials-from-webinar-on-access-to-investigational-drugs-available-.html Did you miss the FDA Basics webinar on "Access to Investigational Drugs"?  Check out the "What's New" box on the FDA Basics home page to download materials from the webinar. There, you will find a link to listen to the entire 30 minute webinar and you can download a copy of the presentation slides. Afia Asamoah Transparency Initiative Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3323618 Tue, 02 Mar 2010 16:19:04 +0100 3323618 http://www.medworm.com/index.php?rid=3284996&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F02%2Fupcoming-events-fda-kicks-of-fda-basics-webinar-series-on-february-23-3-pm-et.html Do you have questions about the use of investigational drugs for treatment purposes? As part of the FDA Basics resource, FDA is hosting a webinar where you can learn more about access to investigational drugs. The featured speakers, Theresa Toigo, Director, Office of Special Health Issues and Richard Klein, HIV/AIDS Program Director, Office of Special Health Issues, will discuss what to consider when deciding whether to seek access to an investigational drug and the ways to access investigational drugs.  There will be time for questions following the presentation. The 30 minute webinar will be held next Tuesday, February 23, at 3 p.m. ET.   You can find out more information about the webinar, including how to participate in ... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3284996 Fri, 19 Feb 2010 13:32:51 +0100 3284996 http://www.medworm.com/index.php?rid=3228424&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F02%2Flearn-about-the-fda-transparency-initiative.html A recently published article, FDA Transparency Initiative: Opening FDA's "Black Box", in the January/February 2010 issue of FDLI Update provides an overview of the agency's Transparency Initiative. Check out the article for a view of the agency's overall plan. Transparency Task Force (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3228424 Mon, 01 Feb 2010 15:40:00 +0100 3228424 http://www.medworm.com/index.php?rid=3164921&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2010%2F01%2Ffda-launches-webbased-resource-to-make-information-about-the-agency-more-easily-available.html Today, as the first phase of the agency's Transparency Initiative, FDA launched a web-based resource called FDA Basics that provides basic information about the agency and how it does its work. Comments from the public, including on this blog, first suggested the idea that FDA provide basic information about the agency in a user-friendly, accessible format.  You can view the FDA Basics resource via a link in the "About FDA" section of the FDA home page, http://www.fda.gov/AboutFDA/Basics.   The FDA Basics resource includes:   ·    Questions and answers about the agency and the products that the agency regulates ·    Short videos that explain various agency activities ·    Conversations with agency personnel about th... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3164921 Tue, 12 Jan 2010 15:00:00 +0100 3164921 http://www.medworm.com/index.php?rid=3236935&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F11%2Ftell-us-your-ideas-how-should-fda-inform-the-public-about-inspection-results--fda-conducts-many-inspections-a-completed-for.html FDA conducts many inspections. A completed Form FDA-483 lists observations made during an inspection of a firm. Responding to Freedom of Information Act (FOIA) requests for these reports of inspectional observations, however, often takes a lot of time because of the need to redact non-public information, such as trade secret and confidential commercial information, from the inspection report.FDA seeks input on whether inspection reports should be re-designed to separate out a summary or key findings page that could be made available to the public quickly. Disclosure of full inspectional observation reports would still require the same review for non-public information as it does now. Does this sound like a good idea? If so, what would be key points to be included in the summary page? What,... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3236935 Sun, 22 Nov 2009 03:12:08 +0100 3236935 http://www.medworm.com/index.php?rid=3015994&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F11%2Ftell-us-your-ideas-how-should-fda-inform-the-public-about-inspection-results--fda-conducts-many-inspections-a-completed-for.html Tell Us Your Ideas: How Should FDA Inform the Public About Inspection Results FDA conducts many inspections. A completed Form FDA-483 lists observations made during an inspection of a firm. Responding to Freedom of Information Act (FOIA) requests for these reports of inspectional observations, however, often takes a lot of time because of the need to redact non-public information, such as trade secret and confidential commercial information, from the inspection report. FDA seeks input on whether inspection reports should be re-designed to separate out a summary or key findings page that could be made available to the public quickly. Disclosure of full inspectional observation reports would still require the same review for non-public information as it does now. Does this sound like a go... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=3015994 Sun, 22 Nov 2009 03:12:08 +0100 3015994 http://www.medworm.com/index.php?rid=2951644&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F11%2Fwatch-and-comment-on-the-task-forces-second-public-meeting.html The second public meeting on transparency can be viewed via live webcast. To view the live webcast click on this link. The link will not be active until November 3, 2009, at 8:30 AM ET. The webcast of the meeting will also be archived on the transparency task force website and can be viewed there 24 hours after the meeting. For details on the day's events, please view the meeting agenda, available here. Afia Asamoah, Public Meeting Coordinator (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2951644 Mon, 02 Nov 2009 22:19:36 +0100 2951644 http://www.medworm.com/index.php?rid=2951645&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F11%2Fground-rules-for-november-3-public-meeting-on-transparency.html - The purpose of this public meeting is to receive in-depth comments on three specific issues related to transparency at FDA. Comments should be limited to those issues. - Each issue will be discussed by a stakeholder panel. Participants on each panel will discuss a hypothetical case study about the issue. Transparency task force members may ask questions of the panel following the discussion. - During the public comment period, audience members may comment for up to 2 minutes each about the case studies. - We are looking forward to a respectful discussion and exchange of ideas. - Comments should be made only when at a microphone and you have been recognized by the Chair of the meeting.- Do not share or reveal information you would not want to be public.- In addition to the public meeting... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2951645 Mon, 02 Nov 2009 22:16:36 +0100 2951645 http://www.medworm.com/index.php?rid=2859847&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F10%2Fupcoming-events-task-force-is-holding-its-second-public-meeting-on-transparency-in-november.html The next public meeting on transparency will be held Tuesday, November 3, 2009. The task force plans to use a discussion group format to receive detailed and in-depth comments on three specific issues related to transparency at FDA. The topics to be covered are: (1) early communication about emerging safety issues concerning FDA-regulated products, (2) disclosure of information about product applications that are abandoned (i.e., no work is being done or will be undertaken to have the application approved) or withdrawn by the applicant before approval, and (3) communication of agency decisions about pending product applications. For each topic, a panel will discuss a case study about the topic and answer questions that may be posed by task force members. Audience members will also have... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2859847 Mon, 05 Oct 2009 11:32:53 +0100 2859847 http://www.medworm.com/index.php?rid=2801811&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F09%2Ffda-101-curriculum.html Part of FDA's transparency initiative is to better explain to the public what the agency does, in a useful, and user-friendly format. The task force would like your help in coming up with a list of questions about the FDA that you would like answers to. For example, possible questions can include: What products does FDA regulate? How do you find out if a medicine is approved by FDA? Your suggestions will be used by the task force to develop a FDA 101 curriculum for consideration by Commissioner Hamburg. Our question is: What questions and topics should be included in a FDA 101 curriculum? How should the agency present that information? We look forward to your feedback and thanks for your participation! Transparency Task Force (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2801811 Wed, 16 Sep 2009 20:39:42 +0100 2801811 http://www.medworm.com/index.php?rid=2710109&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F08%2Fkeep-the-suggestions-coming-transparency-task-force-reopens-public-docket-for-more-comments-.html On August 18, FDA announced in the Federal Register (link to FR notice) that the docket for the transparency task force, available at www.regulations.gov , is re-opening for more comments until November 6, 2009. When the agency announced the formation of the Transparency Task Force, in addition to launching the blog, the task force opened a public docket to solicit comments from the public on improving transparency at the agency. As of August 7, when the docket officially closed, we had received over 900 comments from a range of people -- consumers, patients, healthcare professionals, regulated industry, and others. The task force will use these comments to inform recommendations about transparency at the agency that will be provided in a report to Commissioner Hamburg in about five months... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2710109 Tue, 18 Aug 2009 16:59:23 +0100 2710109 http://www.medworm.com/index.php?rid=2705893&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F08%2Fjoin-the-conversation-meeting-with-the-risk-communication-advisory-committee-to-discuss-product-recalls.html On August 14, Afia Asamoah, coordinator of the agency's transparency initiative, spoke to the Risk Communication Advisory Committee (RCAC) on behalf of the Transparency Task Force. The task force asked the RCAC for thoughts about how the agency can best communicate information to the public about different types of product recalls. The RCAC shared their thoughts about: (1) when the agency should communicate to the public about a product recall, (2) what the agency should say about the recall, and (3) how the agency should communicate to different stakeholders--patients, consumers, healthcare professionals, industry, and others--about a product recall. The RCAC also provided ideas about the importance of tracking whether the agency is doing a good job communicating to the public about p... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2705893 Mon, 17 Aug 2009 13:02:13 +0100 2705893 http://www.medworm.com/index.php?rid=2692869&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F08%2Ffda-transparency-initiative-meeting-held-to-discuss-opportunities-for-fda-to-foster-innovation.html On August 11, the White House Office of Science, Technology, and Policy (OSTP) hosted a meeting with FDA Principal Deputy Commissioner, Dr. Joshua Sharfstein, United States Chief Technology Officer, Aneesh Chopra, members of the White House Open Government Initiative, and the health care investor community at the White House to discuss ways FDA can make useful and understandable information available about the product approval process and how transparency at FDA can foster medical product innovation. Participants included individuals who invest in small, mid-size, and large companies that develop a range of products regulated by FDA. During the conversation, participants provided feedback to FDA and OSTP in three main areas: (1) how FDA can better explain its processes and operations, (2) ... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2692869 Wed, 12 Aug 2009 16:52:36 +0100 2692869 http://www.medworm.com/index.php?rid=2631466&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F07%2Ffor-further-discussion-comment-from-the-public-about-transparency-2.html The views and opinions expressed in this comment are those of the author only and should not be regarded as those of the Transparency Task Force or FDA. The comment is posted by the Transparency Task Force simply to facilitate discussion.   My recommendation relates to cases where FDA does not approve one of the indications requested in a New Drug Application (NDA) or does not approve an indication requested in a Supplemental New Drug Application.  In such cases, FDA should make public the “non-approval letter” explaining why the indication was not approved, the relevant analysis by FDA’s medical officer and all clinical trials that were the basis for FDA’s non-approval. When a drug is marketed for at least one approved indication, it is foreseeable it will also be pres... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2631466 Fri, 24 Jul 2009 01:30:24 +0100 2631466 http://www.medworm.com/index.php?rid=2607148&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F07%2Ffor-further-discussion-comment-from-the-public-about-transparency-.html The Transparency Task Force is trying something new. Every once in a while, we will post a comment we have received on this main page. The Task Force would like to hear from more people about the views expressed in these comments. These comments will be from a diverse group of stakeholders and each comment will present a view about transparency at FDA. We will ask the author before reposting the comment here. The views and opinions expressed in these comments are those of the authors only and should not be regarded as those of the Transparency Task Force or FDA. The comments are posted by the Transparency Task Force simply to facilitate discussion. The first posting is from Jeffrey Francer of the Pharmaceutical Research and Manufacturers of America. The Pharmaceutical Research and Manuf... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2607148 Fri, 17 Jul 2009 01:51:30 +0100 2607148 http://www.medworm.com/index.php?rid=2603421&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F07%2Fcomment-on-the-sentinel-initiative.html In line with FDA’s Transparency Task Force efforts, FDA is encouraging public comment on the Sentinel Initiative. The Sentinel Initiative is an FDA collaborative effort to develop a national electronic system (Sentinel System) that will transform FDA’s ability to track the safety of drugs, biologics, medical devices—ultimately all FDA-regulated products—once they reach the market.  By seeking public comment via an open discussion room, FDA is expanding its ability to get new ideas and guidance from the public in near real time. To contribute ideas on the Initiative and related documents, please visit http://www.fda.gov/Safety/FDAsSentinelIn... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2603421 Wed, 15 Jul 2009 14:43:25 +0100 2603421 http://www.medworm.com/index.php?rid=2563797&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F07%2Fhow-can-fda-use-its-website-to-improve-transparency-at-the-agency.html On June 24, we held our first public meeting to hear ideas from the public about transparency at the agency.  During the meeting, some attendees told us that the FDA should use its website, www.fda.gov, to improve communications with the public. The task force would like continue this conversation and hear from more people about how FDA can use the website to be more effective in providing useful and understandable information to the public.  Our question is: How can FDA use its website to improve transparency at the agency?      Thank you and we look forward to your input and participation. FDA Transparency Task Force   (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2563797 Thu, 02 Jul 2009 19:55:47 +0100 2563797 http://www.medworm.com/index.php?rid=2550587&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F06%2Fcomments-on-june-24-public-meeting.html FDA held its first public meeting last Wednesday to solicit input from the public on ways the agency can make useful and understandable information about FDA activities and decision making more readily available to the public in a timely manner and in a user-friendly format. Thirty five speakers, including patients, consumers, regulated industry, advocacy groups, and others, shared their suggestions about improving transparency at the agency with task force members and their designees. The meeting was webcast live and can also be viewed online here. We are interested in your feedback on the meeting. What parts of the meeting did you find helpful? How can FDA make the next meeting better? Thank you and we look forward to your input and participation. FDA Transparency Task Force (Source: FDA... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2550587 Mon, 29 Jun 2009 12:41:13 +0100 2550587 http://www.medworm.com/index.php?rid=2485601&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F06%2Fwatch-and-comment-on-the-task-forces-public-meeting.html For those of you who are unable to attend the public meeting in person, the Task Force has made the meeting viewable via webcast. The link to the live program will not be active until June 24, 2009, at 7:30 AM ET. For details on the day's events please view the meeting's agenda. We look forward to your participation. Erik P. Mettler, MPA, MPH FDA Transparency Blog Managing Director (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2485601 Wed, 24 Jun 2009 02:26:38 +0100 2485601 http://www.medworm.com/index.php?rid=2485602&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F06%2Fthe-transparency-task-forces-sixth-question.html We want to know how the FDA could provide information to the public to better explain the agency's work and its decisions. The sixth question is: What metrics should FDA use to gauge the effectiveness of its transparency efforts? Thank you and we look forward to your input and participation. FDA Transparency Task Force (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2485602 Wed, 24 Jun 2009 01:43:08 +0100 2485602 http://www.medworm.com/index.php?rid=2485603&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F06%2Fthe-transparency-task-forces-fifth-question.html We want to know how the FDA could provide information to the public to better explain the agency's work and its decisions. The fifth question is: As FDA becomes more transparent, what information should remain confidential in order to promote key internal and external policy goals, such as preserving patient privacy, and how, in these cases, should FDA explain the importance of confidentiality? Thank you and we look forward to your input and participation. FDA Transparency Task Force (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2485603 Tue, 23 Jun 2009 12:39:31 +0100 2485603 http://www.medworm.com/index.php?rid=2485604&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F06%2Fground-rules-for-june-24-public-meeting-on-transparency.html -  This public meeting is about transparency at FDA, how the agency can make understandable and useful information available to the public. Comments should be limited to this topic. - Comments should be limited to 5 minutes to permit adequate time for questions from the panel and to allow time for an open comment session later in the day.  During the open comment session, attendees who did not register to speak can make comments. -  Registered speakers will be organized into panels of three.  We have attempted to group registered speakers thematically, based on the brief description each speaker provided when he or she registered to speak.  Admittedly, this is an imperfect science and speakers in some groups may be speaking on different topics.   ... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2485604 Mon, 22 Jun 2009 10:44:19 +0100 2485604 http://www.medworm.com/index.php?rid=2485605&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F06%2Fthe-transparency-task-forces-fourth-question.html We want to know how the FDA could provide information to the public to better explain the agency's work and its decisions. The fourth question is:   What, if any, legislative or regulatory changes are needed to improve FDA's ability to provide useful and understandable information to the public? Thank you and we look forward to your input and participation. FDA Transparency Task Force (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2485605 Sun, 21 Jun 2009 20:17:58 +0100 2485605 http://www.medworm.com/index.php?rid=2485606&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F06%2Fwould-you-like-to-have-a-statement-read-at-the-the-task-force-public-meeting.html If you cannot attend the public meeting on transparency in person and would like to have a statement read at the June 24th Transparency Task Force public meeting, please email that statement to Transparency.Meeting@fda.hhs.gov. The statement will be read to the Task Force by a FDA staff member during the public meeting. The statement should be 5 minutes or less so we can accommodate all people who want to speak.   Note: Statements should be submitted by 5 p.m. Monday, June 22.   Thank you and we look forward to your input and participation. FDA Transparency Task Force     (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2485606 Thu, 18 Jun 2009 18:28:01 +0100 2485606 http://www.medworm.com/index.php?rid=2485607&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F06%2Fthe-transparency-task-forces-third-question.html We want to know how the FDA could provide information to the public to better explain the agency's work and its decisions. The third question is:   What tools, techniques, processes, or other mechanisms should FDA use to be more effective in providing useful and understandable information? Internet tools? Tools to improve targeting and effectiveness of communications, including risk communication? Improvements to the Freedom of Information Act processes? Other? Thank you and we look forward to your input and participation. FDA Transparency Task Force (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2485607 Thu, 18 Jun 2009 11:06:13 +0100 2485607 http://www.medworm.com/index.php?rid=2478780&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F06%2Fresponse-to-some-comments.html In response to a few of the comments that have come in we have added a new section to the “About This Blog” page. On that page you will now find a description of the Task Force’s Actions and Membership. We will also provide a webcast of the Public Meeting on the 24th. The link to the webcast will provided here in a separate post as well as on the Task Force website. The webcast will also be available for viewing online after the public meeting. If you have any other suggestions on how we can improve this blog and make it more useful please let us know. Thank you and we look forward to your input and participation. FDA Transparency Task Force (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2478780 Tue, 16 Jun 2009 12:02:08 +0100 2478780 http://www.medworm.com/index.php?rid=2474638&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F06%2Fthe-transparency-task-forces-second-question.html We want to know what information FDA could give to the public to better explain the agency's work and its decisions. The second question is:   What specific information should FDA provide about agency operations, activities, processes, and decision making, including: Enforcement Actions? Product Approvals? Recalls? Other Actions? Thank you and we look forward to your input and participation. FDA Transparency Task Force (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2474638 Sun, 14 Jun 2009 19:09:48 +0100 2474638 http://www.medworm.com/index.php?rid=2464582&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F06%2Ftransparency-public-meeting-structure-and-format.html We are seeking advice on the best way to structure the June 24, 2009 public meeting on transparency.   The agency typically organizes public meetings by the order in which presenters submit their speaking requests to the agency.  This approach has varied results as it can be difficult to locate a particular meeting or to review comments associated with a particular topic after the meeting.  We have come up with additional options below for organizing the June 24 public meeting and we are interested in your input. By Product (e.g., drugs/biologics, medical devices, foods, cosmetics, dietary supplements) By Agency Action (e.g., review of product applications and product approvals, enforcement actions, recalls, public education and outreach to stakeholders) By Qu... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2464582 Mon, 08 Jun 2009 20:41:47 +0100 2464582 http://www.medworm.com/index.php?rid=2464583&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F06%2Fthe-transparency-task-forces-first-question.html The Transparency Task Force is actively seeking input from the public about issues related to transparency and will work to identify what information the public most wants FDA to be transparent about.  The public comments will inform the recommendations the Task Force will provide to the Commissioner about ways the agency can become more transparent. To fully utilize this blog and help categorize and focus the conversations on it we will post a new question and/or topic every week until the Transparency Task Force public meeting is held on Wednesday, June 24, 2009. We will begin by posting, one at a time, the questions we asked in the Federal Register notice we published on June 3, 2008.   The first question is relatively general.  Still, we re... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2464583 Thu, 04 Jun 2009 18:46:10 +0100 2464583 http://www.medworm.com/index.php?rid=2464584&cid=s_38622_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2009%2F06%2Ftransparency-blog.html I want to thank Peggy Hamburg and the team at FDA for their leadership and work to make the FDA open and transparent. Our Administration is committed to eliminating the barriers between the American people and their government, and the Task Force is another big step in the right direction. The FDA is responsible for protecting the food we eat and the medicine we use -- its work impacts every American, and ensuring the agency is open and accountable to the American people is critical. Thank you for taking the time to visit the Task Force blog and learn more about this effort.  We appreciate your thoughts and ideas and look forward to hearing from you. Sincerely, Secretary Kathleen Sebelius U.S. Department of Health and Human Services BackgroundProviding information to the pu... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=2464584 Tue, 02 Jun 2009 20:00:00 +0100 2464584