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Watch and Comment on the Task Force's Second Public MeetingEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA Transparency Blog - November 2, 2009 Category: American Health Authors: HHS Source Type: blogs

Ground Rules for November 3 Public Meeting on TransparencyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
- 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 mi...
Source: FDA Transparency Blog - November 2, 2009 Category: American Health Authors: HHS Source Type: blogs

Upcoming Events: Task Force is Holding its Second Public Meeting on Transparency in NovemberEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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applications that are abandoned (i.e., no work is being done or will be undertaken to have the application approved) or withdrawn by the applicant before approval, and (3) communication of agency decisions about pending product appl...
Source: FDA Transparency Blog - October 5, 2009 Category: American Health Authors: HHS Source Type: blogs

FDA 101 CurriculumEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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 ...
Source: FDA Transparency Blog - September 16, 2009 Category: American Health Authors: HHS Source Type: blogs

Keep the Suggestions Coming: Transparency Task Force Re-opens Public Docket for More CommentsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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 ta...
Source: FDA Transparency Blog - August 18, 2009 Category: American Health Authors: HHS Source Type: blogs

Join the Conversation: Meeting with the Risk Communication Advisory Committee to Discuss Product RecallsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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, an...
Source: FDA Transparency Blog - August 17, 2009 Category: American Health Authors: HHS Source Type: blogs

FDA Transparency Initiative: Meeting Held to Discuss Opportunities for FDA to Foster InnovationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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 regula...
Source: FDA Transparency Blog - August 12, 2009 Category: American Health Authors: HHS Source Type: blogs

For Further Discussion -- Comment from the Public About Transparency #2Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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 ...
Source: FDA Transparency Blog - July 24, 2009 Category: American Health Authors: HHS Source Type: blogs

For Further Discussion -- Comment from the Public About TransparencyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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 simpl...
Source: FDA Transparency Blog - July 17, 2009 Category: American Health Authors: HHS Source Type: blogs

Comment on the Sentinel InitiativeEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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 guidan...
Source: FDA Transparency Blog - July 15, 2009 Category: American Health Authors: HHS Source Type: blogs

How Can FDA Use its Website to Improve Transparency at the Agency?Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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 parti...
Source: FDA Transparency Blog - July 2, 2009 Category: American Health Authors: HHS Source Type: blogs

Comments on June 24 Public MeetingEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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 meeti...
Source: FDA Transparency Blog - June 29, 2009 Category: American Health Authors: HHS Source Type: blogs

Watch and Comment on the Task Force's Public MeetingEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA Transparency Blog - June 24, 2009 Category: American Health Authors: HHS Source Type: blogs

The Transparency Task Force’s Sixth QuestionEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA Transparency Blog - June 24, 2009 Category: American Health Authors: HHS Source Type: blogs

The Transparency Task Force’s Fifth QuestionEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA Transparency Blog - June 23, 2009 Category: American Health Authors: HHS Source Type: blogs

Ground Rules for June 24 Public Meeting on TransparencyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
- 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 pr...
Source: FDA Transparency Blog - June 22, 2009 Category: American Health Authors: HHS Source Type: blogs

The Transparency Task Force’s Fourth QuestionEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA Transparency Blog - June 21, 2009 Category: American Health Authors: HHS Source Type: blogs

Would you like to have a statement read at the the Task Force public meeting?,Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA Transparency Blog - June 18, 2009 Category: American Health Authors: HHS Source Type: blogs

The Transparency Task Force’s Third QuestionEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA Transparency Blog - June 18, 2009 Category: American Health Authors: HHS Source Type: blogs

Response to Some CommentsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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 par...
Source: FDA Transparency Blog - June 16, 2009 Category: American Health Authors: HHS Source Type: blogs

The Transparency Task Force’s Second QuestionEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA Transparency Blog - June 14, 2009 Category: American Health Authors: HHS Source Type: blogs

Transparency Public Meeting Structure and FormatEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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 suppl...
Source: FDA Transparency Blog - June 8, 2009 Category: American Health Authors: HHS Source Type: blogs

The Transparency Task Force’s First QuestionEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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...
Source: FDA Transparency Blog - June 4, 2009 Category: American Health Authors: HHS Source Type: blogs

Introducing the FDA Transparency BlogEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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 ...
Source: FDA Transparency Blog - June 2, 2009 Category: American Health Authors: HHS Source Type: blogs