The leading publisher of FDA News, FDA Review, FDA Compliance, QSR News, and Food Drug Administration information since 1984. http://fdaweb.com/ Thu, 17 May 2012 20:47:49 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121776 The Senate begins work on the FDA user fee reauthorization bill (S. 3187), with majority leader Harry Reid (D-NV) urging Republicans to not hold up the measure. Thu, 17 May 2012 13:05:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121776 http://fdaweb.com/login.php?sa=v&aid=D5121775 PhRMA says it is concerned that an FDA draft guidance on a mandatory pre-dissemination review program for direct-to-consumer television ads is "overbroad, unduly burdensome, and lacking in narrow, objective, and definitive standards." Thu, 17 May 2012 11:00:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121775 http://fdaweb.com/login.php?sa=v&aid=D5121774 FDA approves a Medgenics, Inc. IND for a Phase 2b clinical trial of Epodure to produce and deliver erythropoietin for treating anemia in renal dialysis patients. Thu, 17 May 2012 10:55:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121774 http://fdaweb.com/login.php?sa=v&aid=D5121773 Federal Register Final rule: FDA amends the animal drug regulations to reflect March 2012 approval actions and to announce the availability of approval summaries. Thu, 17 May 2012 10:52:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121773 http://fdaweb.com/login.php?sa=v&aid=D5121772 FDA announces approval for eight manufacturers of generic Plavix in 75 mg and 300 mg strengths. Thu, 17 May 2012 09:25:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121772 http://fdaweb.com/login.php?sa=v&aid=D5121771 Pfizer says a Phase 3 study evaluating Torisel (temsirolimus) in patients with advanced renal cell carcinoma, whose disease had progressed on or after Sutent, did not meet the primary endpoint. Thu, 17 May 2012 08:38:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121771 http://fdaweb.com/login.php?sa=v&aid=D5121770 FDA says it does not have a policy alleged in a Perrigo petition that always allows applicants for OTC generic drugs to use bioequivalence studies from the branded prescription product. Thu, 17 May 2012 06:38:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121770 http://fdaweb.com/login.php?sa=v&aid=D5121769 FDA's New York District Office warns Acorda Therapeutics about its failure to properly report adverse drug experiences. Thu, 17 May 2012 06:36:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121769 http://fdaweb.com/login.php?sa=v&aid=D5121768 The American Society of Health-System Pharmacists says it fears that clinicians could become fatigued by receiving too many FDA drug safety communications. Thu, 17 May 2012 06:28:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121768 http://fdaweb.com/login.php?sa=v&aid=D5121767 FDA publishes an addendum to a 1997 International Conference on Harmonization guidance on preclinical safety evaluation of biotechnology-derived pharmaceuticals. Thu, 17 May 2012 05:34:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121767 http://fdaweb.com/login.php?sa=v&aid=D5121766 FDA says it is reviewing safety data on Pfizer's Zithromax (azithromycin) after a study published in the New England Journal of Medicine reported a small increase in cardiovascular death associated with the antibiotic. Thu, 17 May 2012 05:32:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121766 http://fdaweb.com/login.php?sa=v&aid=D5121765 CDRH associate director Kimberly Trautman assures an industry conference there's no cause for concern about the demise in October of the Global Harmonization Task Force on Medical Devices, and she describes its successor. Thu, 17 May 2012 05:08:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121765 http://fdaweb.com/login.php?sa=v&aid=D5121764 FDA clears Mauna Kea Cellvizio miniprobes. Wed, 16 May 2012 16:08:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121764 http://fdaweb.com/login.php?sa=v&aid=D5121763 A new study finds that over the last decade, FDA has approved novel therapeutic agents faster than regulators at the European Medicines Agency and Health Canada. Wed, 16 May 2012 14:32:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121763 http://fdaweb.com/login.php?sa=v&aid=D5121762 An FDA-483 obtained by FDA Webview details quality and medical device reporting violations from a 2009 Mako Surgical inspection. Wed, 16 May 2012 12:49:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121762 http://fdaweb.com/login.php?sa=v&aid=D5121761 RQV Consulting regulatory and compliance specialist Rosario Quintero-Vives says there are seven steps companies should take in advance to ease the stress of an FDA investigation. Wed, 16 May 2012 12:41:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121761 http://fdaweb.com/login.php?sa=v&aid=D5121760 Senate majority leader Harry Reid (D-NV) places the Health, Education, Labor and Pensions Committee's recently approved user fee bill (S.3187) on the chamber's calendar and hopes to begin working on the measure early next week. Wed, 16 May 2012 10:58:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121760 http://fdaweb.com/login.php?sa=v&aid=D5121759 Repros Therapeutics requests a Special Protocol Assessment from FDA for its Androxal Phase 3 pivotal studies. Wed, 16 May 2012 10:57:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121759 http://fdaweb.com/login.php?sa=v&aid=D5121758 Wed, 16 May 2012 10:18:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121758 http://fdaweb.com/login.php?sa=v&aid=D5121757 FDA says Hospira has stopped temporary importing of Canadian-approved methotrexate injection. Wed, 16 May 2012 10:17:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5121757