MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'inspections'. Sat, 03 Sep 2011 02:51:07 +0100 http://www.medworm.com/index.php?rid=4872884&cid=t_154897_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=t_154897_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=4125280&cid=t_154897_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfB8CHD15wQY%2F In a scathing report, the US General Accountability Office has determined that the FDA failed to implement earlier recommendations that would close the gap between the agency’s approach to inspecting domestic and foreign drug manufacturing facilities. Consequently, the GAO writes that it is unclear if steps being taken by FDA “will prove successful” and there is an “urgent need” to better protect public health by putting GAO suggestions into practice. Here are some key findings: The FDA boosted its budget for foreign inspections to $41 million in fiscal 2009 compared with $12 million in fiscal 2008 and $10 million in fiscal 2007, and increased the number of foreign inspections. In fiscal year 2009, for instance, the FDA conducted 424 foreign inspections, compa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4125280 Mon, 01 Nov 2010 15:29:16 +0100 4125280 http://www.medworm.com/index.php?rid=3092865&cid=t_154897_133_f&fid=35090&url=http%3A%2F%2Faspiehomeeducation.blogspot.com%2F2009%2F12%2Fselect-committee-criticises-plans-to.html The Select Committee Report is now available here. Pdf version here.Balls's plans for home education should be scaled back, Sheerman says. Select committee criticises plans to monitor home-educating families as 'too aggressive'. Read it here.Change urged for home-school plan - Parents who choose to home-school their child should not be forced to register with their local council, a cross-party group of MPs has said. More here...More parents 'educating children at home' - Growing numbers of parents are shunning state schools to educate their children at home, according to MPs. Here.The Big Question: Should the parents of home-schooled children be forced to register? - Why are we asking this now? A report by the House of Commons Select Committee covering education, published this morning, is... Aspie Home-Education blogs http://www.medworm.com/rss/comments.php?id=3092865 Wed, 16 Dec 2009 12:01:00 +0100 3092865 http://www.medworm.com/index.php?rid=3044944&cid=t_154897_133_f&fid=35090&url=http%3A%2F%2Faspiehomeeducation.blogspot.com%2F2009%2F12%2Fplease-dont-be-surveyed-by-ofsted.html Taken from here. ****Please feel free to cross post this message freely to all lists, blogs and social media - especially to local lists within the 15 designated counties.****It is clear from recent exchanges with OFSTEd as well as their track record, that their recent attempt to try out a dry run of the kind of inspection regime of home educators, that they would like to take on as new work for themselves, would be to the detriment of home educators, and that there is nothing to be gained from assisting OFSTEd in their ambitions over us by supplying them with vital intelligence useful in creating this new role for themselves. As with the government, their interest is clearly predatory upon us, and the exercise assumes a change in the law mandating such inspections, which home educators ar... Aspie Home-Education blogs http://www.medworm.com/rss/comments.php?id=3044944 Tue, 01 Dec 2009 14:04:00 +0100 3044944 http://www.medworm.com/index.php?rid=2517191&cid=t_154897_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F06%2F26%2Frecent-health-related-statutory-instruments%2F Draft SI 2009 No. 000 Human Fertilisation And Embryology The Human Fertilisation and Embryology (Special Exemption) Regulations 2009 SI 2009 No. 1508 Children And Young Persons, England The Childcare (Inspections) (Amendment) Regulations 2009 SI 2009 No. 1507 Children And Young Persons, England The Childcare (Fees) (Amendment) Regulations 2009 SI 2009 No. 1517 Environmental Protection, England and Wales The Pollution Prevention and Control (Designation of Directives) (England and Wales) Order 2009 SI 2009 No. 1510 National Health Service, England The George Eliot Hospital National Health Service Trust (Establishment) Amendment Order 2009 SI 2009 No. 1503 (C. 76) Children And Young Persons, England And Wales Children And Young Persons, Northern Ireland Protection Of Vulnerable Adults, Engla... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2517191 Fri, 26 Jun 2009 08:21:54 +0100 2517191 http://www.medworm.com/index.php?rid=1901976&cid=t_154897_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F428432720%2F How about 13 years? That’s the conclusion of a new report by the General Accountability Office, which notes there are currently 3,249 foreign manufacturing plants that make meds for the US market and would need to be visited. The report (here it is) concludes the FDA is nowhere near to closing an oversight gap so foreign facilities get the same scrutiny as domestic plants, the Associated Press reports. Pharma plants in the US get a federal inspection every 2.7 years, on average. Although the FDA will soon be placing inspectors in China and India, “given the growth in foreign drug manufacturing for the US market, and the large gaps in FDA’s foreign drug inspection program, significant challenges remain,” the GAO writes. The report “confirms that the system dep... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1901976 Wed, 22 Oct 2008 10:33:44 +0100 1901976 http://www.medworm.com/index.php?rid=1603407&cid=t_154897_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F331625627%2F Nice to see you again. We were up quite early today foraging for interesting items and researching others. So now we will tend to the official Pharmalot mascot and grab some coffee. Meanwhile, we hope your day gets off to a good start… US, Europe & Australia Unite On Drug Inspections (Associated Press) Shareholders Approve Biogen Board (Yahoo/Reuters) Novartis Closing Two Sites In France (Thomson Financial) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1603407 Thu, 10 Jul 2008 10:49:17 +0100 1603407 http://www.medworm.com/index.php?rid=1516777&cid=t_154897_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F311340134%2F So if drugmakers can outsource the manufacture of active pharmaceutical ingredients, why can’t the FDA outsource the inspections? That’s one possibility being considered by both the agency and some members of Congress amid debate and turmoil over FDA funding and tainted goods, Reuters reports. Nearly 80 percent of ingredients used in meds sold in the US come from China and India, according to the FDA, but last year, just 83 plants in those countries were inspected. But critics say a multimillion-dollar program to use third-party inspectors to boost inspections of medical devices has flopped. It took the FDA two years to approve the first private inspectors that can be hired to check facilities. Since then, 12 third-party inspections have been conducted, according to Daniel Schu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1516777 Fri, 13 Jun 2008 19:05:36 +0100 1516777 http://www.medworm.com/index.php?rid=1416442&cid=t_154897_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F282073184%2F When it comes to the Heparin scandal, about the only thing anyone can seem to agree is on that the FDA needs to conduct more inspections of foreign manufacturing facilities. But how this would be accomplished - and funded - is the big question. And a congressional hearing yesterday seemed to do little to provide an answer. A bill proposed by John Dingell, the Michigan Democrat who chairs the House Energy and Commerce Committee, would impose an annual fee for all domestic and foreign drugmakers to defray the costs. Foreign drugmakers would have to be inspected every two years like domestic manufacturers, a requirement that doesn’t exist right now. Industry trade groups told Congress they’re willing to discuss a new user-fee system, within limits. Their issues include the size o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1416442 Fri, 02 May 2008 12:24:39 +0100 1416442 http://www.medworm.com/index.php?rid=1248995&cid=t_154897_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F239030882%2F In the wake of the scandal over Heparin and the failure of the FDA to inspect the Chinese plant that supplied the active ingredient for the blood thinner, the House Energy and Commerce Committee has sent a letter to Mike Leavitt, the Health and Human Services Secretary, suggesting emergency legislation may be in the cards to “protect Americans from prescription medications that have been insufficiently investigated prior to approval.” “These Heparin tragedies are likely the result of FDA abandoning its preapproval inspection requirement, a critical policy was put in place two decades ago after a generic drug investigation by this Committee,” Dingell says in a statement. “This requirement was designed to protect consumers by ensuring that drug manufacturers operate... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1248995 Thu, 21 Feb 2008 21:41:31 +0100 1248995 http://www.medworm.com/index.php?rid=908788&cid=t_154897_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F162006436%2F In fact, the FDA can’t come close to conducting regular safety inspections of overseas facilities making meds and bulk ingredients imported into the US. Steven Solomon, deputy director of the FDA’s Office of Regulatory Affairs, told a House Energy and Commerce subcommittee yesterday the agency can only inspect “several hundred” foreign facilities a year - out of almost 3,000 - because of a shortage of staff and resources. And FDA Deputy Commissioner Randy Lutter told the panel that pharmaceutical operations in the US are supposed to be inspected every two years to ensure good manufacturing and safety practices, but the agency doesn’t have enough inspectors to come anywhere near that goal overseas. In response to a question, Lutter confirmed some companies exp... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=908788 Thu, 27 Sep 2007 14:11:48 +0100 908788