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 'fda warning letters'. Sat, 03 Sep 2011 03:29:14 +0100 http://www.medworm.com/index.php?rid=4168208&cid=t_282032_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWoFKcVzc854%2F Mention the phrase ‘white paper’ and an authoritative guide to a particular policy issue may spring to mind. Of course, white papers may also be nothing more than promotional thoughts dressed up as think pieces. And that’s what the FDA has decided the Ipsen Group did in creating and distributing a paper about Insulin-like Growth Factor Deficiency, an affliction in which growth is inhibited. In a recently disclosed warning letter, the agency took Ipsen to task for omitting important risk info and broadenening the indication for its Increlex treatment. But the underlying issue was that the white paper wasn’t really a white paper and there were several tell-tale signs that offer some interesting insight into agency thinking on such situations. To wit, the FDA noted the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4168208 Mon, 15 Nov 2010 17:13:53 +0100 4168208 http://www.medworm.com/index.php?rid=3999298&cid=t_282032_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FFZ0JwxcX8g4%2Fcan-fda-keep-up-with-pharma-advertising.html AccessRx.com looks at the current balancing act Pharma companies are playing with the FDA while advertising to consumers. The USA and New Zealand are the only two countries in the world that allow Pharma companies to advertise to their consumers. The Pharma companies spend over $4.8 billion every year. The FDA regulates these ads, but is often far behind in monitoring and enforcing their policies on the ads.What do you think the FDA can do to better patrol Pharma Marketing? While the number of warning letters from the FDA has increased from 21 in 2008 to 45 as of August this year, the FDA is having trouble with the volume of advertising and reviewing campaigns. (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3999298 Fri, 24 Sep 2010 13:12:00 +0100 3999298 http://www.medworm.com/index.php?rid=3511776&cid=t_282032_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FiKJQxS2m-mc%2F Earlier this month, the FDA sent Pfizer a warning letter for failing to properly monitor pediatric clinical trials in which at least 13 children with bipolar disorder experienced overdosing that led to restless legs, tremors, involuntary facial movements and a serious skin disorder. This is a big problem for the drugmaker, since Pfizer hopes to receive an extra six months of marketing exclusivity in return for having conducted the pediatric trials. But the dosing scandal could prompt the FDA to request further trials, which would require so much additional time that exclusivity would likely be lost, since the basic Geodon patent expires in 2012. This would also delay pediatric approval, which would expand the possibilities for a drug that generated $1.1 billion in sales last year. But who ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3511776 Wed, 28 Apr 2010 13:58:00 +0100 3511776 http://www.medworm.com/index.php?rid=3483120&cid=t_282032_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYtTuaEgi9dM%2F For those tracking the missives sent by the agency to drugmakers, here is a quick round-up of letters that were posted late last week on the FDA web site. Interestingly, two of the violations involve a web page and an email. GlaxoSmithKline was tagged for placing an ad in the Dec. 1, 2009, issue of the Journal of Clinical Oncology that was cited for being false and misleading for omitting safety and effectiveness info about Arzerra (here’s the letter and here’s the ad). In another letter, sent to Astallas Pharma and Glaxo, which have a partnership to promote the Vesicare bladder control drug, the FDA charged that a web site promotion is “false or misleading because it presents unsubstantiated superiority claims and overstates efficacy” (here’s the letter and the w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3483120 Mon, 19 Apr 2010 11:51:35 +0100 3483120 http://www.medworm.com/index.php?rid=2719764&cid=t_282032_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FZGZcwKYooPs%2F Ibuprofen (Advil, for example), is a commonly used pain medication that is taken by mouth. However, some unscrupulous people have been selling topical ibuprofen over-the-counter, meaning ibuprofen in a cream or ointment. What concerns the FDA is that there is no proof that ibuprofen in a topical form in any over-the-counter products. They’ve sent warning letters to eight companies who are selling the products. According to the FDA press release: The names of the products and manufacturers that received warning letters are: Emuprofen (Progressive Emu, Inc.) BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.) Ibunex Topical Ibuprofen (Core Products International, Inc.) LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products) IB-RELIEF (MEKT LLC) Profen HP (Ridge Medical ... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2719764 Fri, 21 Aug 2009 00:25:51 +0100 2719764 http://www.medworm.com/index.php?rid=1500280&cid=t_282032_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F306362658%2F Over the past 10 years, there was a drop by about half, in fact, Dow Jones reports. A big falloff began in 2002, when the agency began requiring all warnings go through its chief counsel office, which was supposedly designed to make the letters legally consistent and credible, the wire notes. The year before this change took effect, in fiscal year 2001, the FDA issued 1,032 warning letters. In 2006, the FDA sent 538 letters, and in 2007 it sent 471, FDA data show. Some members of Congress, FDA staffers and former FDA officials have criticized the change, suggesting it favored industry. “The number of warning letters has always been one of the surrogate measures of FDA’s enforcement performance,” David Kessler, who was FDA commish from 1990 to 1997, tells Dow Jones. &#822... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1500280 Fri, 06 Jun 2008 21:57:30 +0100 1500280