The leading publisher of FDA News, FDA Review, FDA Compliance, QSR News, and Food Drug Administration information since 1984. http://fdaweb.com/ Thu, 23 May 2013 08:36:23 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125300 An FDA advisory committee votes 13-3 to recommend approval of Merck's insomnia drug suvorexant (15-20mg), but the panel members were mixed in a 7-8 vote to not recommend a higher dose due to safety concerns. Wed, 22 May 2013 14:17:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125300 http://fdaweb.com/login.php?sa=v&aid=D5125299 Ahead of reported massive global layoffs and in response to a huge $500 million penalty for making and distributing adulterated drugs, Ranbaxy says it has "instituted a rigorous new code of conduct for all Ranbaxy employees, with clear accountability for compliance." Wed, 22 May 2013 11:52:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125299 http://fdaweb.com/login.php?sa=v&aid=D5125298 FDA accepts an Upsher-Smith Laboratories NDA for USL255 for managing epilepsy in adults. Wed, 22 May 2013 11:26:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125298 http://fdaweb.com/login.php?sa=v&aid=D5125297 Federal Register Notice: FDA's Science Board to the FDA will meet 6/24 to hear reports from the CDRH Research Review subcommittee and the Global Health subcommittee. Wed, 22 May 2013 11:25:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125297 http://fdaweb.com/login.php?sa=v&aid=D5125296 Federal Register Notice: FDA plans a public meeting 7/25-26 to obtain input on standardizing and assessing risk evaluation and mitigation strategies (REMS) for drug and biological products. Wed, 22 May 2013 11:23:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125296 http://fdaweb.com/login.php?sa=v&aid=D5125295 Federal Register Notice: FDA seeks comments on CLIA categorization of in vitro diagnostic tests when premarket review is not needed. Wed, 22 May 2013 11:22:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125295 http://fdaweb.com/login.php?sa=v&aid=D5125294 Federal Register Final rule: FDA amends the animal drug regulations to reflect April NADA and ANADA approval actions and the availability summaries for the basis of approval. Wed, 22 May 2013 11:21:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125294 http://fdaweb.com/login.php?sa=v&aid=D5125293 The Senate HELP Committee sends to the full Senate legislation creating a new class of compounding pharmacies to be regulated by FDA. Wed, 22 May 2013 10:57:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125293 http://fdaweb.com/login.php?sa=v&aid=D5125292 Five drug companies voice basic support for a revised ICH guidance document on rodent carcinogenicity testing of drugs. Wed, 22 May 2013 09:38:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125292 http://fdaweb.com/login.php?sa=v&aid=D5125291 FDA approves Bausch & Lomb's Trulign Toric posterior chamber intraocular lens. Wed, 22 May 2013 08:22:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125291 http://fdaweb.com/login.php?sa=v&aid=D5125290 CDER issues "dos and don'ts" Best Email Practices for employees responding to internal and external emails to avoid common and embarrassing email mistakes. Wed, 22 May 2013 08:17:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125290 http://fdaweb.com/login.php?sa=v&aid=D5125289 FDA tells Biosense Technologies its mobile phone app for reading urine analysis dipsticks needs agency clearance for marketing. Wed, 22 May 2013 07:31:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125289 http://fdaweb.com/login.php?sa=v&aid=D5125288 PhRMA, BIO, and Genentech praise FDA's draft model for benefit-risk determination in drug and biologic reviews. Wed, 22 May 2013 07:27:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125288 http://fdaweb.com/login.php?sa=v&aid=D5125287 The Center for Science in the Public Interest says it supports a Pharmacists Planning Service petition asking FDA to move St. John's wort behind the pharmacy counter. Wed, 22 May 2013 05:13:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125287 http://fdaweb.com/login.php?sa=v&aid=D5125286 In an unusual discussion of new-drug cost for an FDA leader, CDER director Janet Woodcock believes industry may want to carefully weigh therapy cost-benefit in the new era of personalized medicine. Tue, 21 May 2013 16:14:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125286 http://fdaweb.com/login.php?sa=v&aid=D5125285 Novartis asks the Supreme Court to determine whether a state jury can impose punitive damages on a drug company in a suit involving lawful marketing of a prescription drug. Tue, 21 May 2013 13:23:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125285 http://fdaweb.com/login.php?sa=v&aid=D5125284 FDA warns Boehringer-Ingelheim about CGMP violations at its German manufacturing facility for APIs and finished drugs. Tue, 21 May 2013 13:22:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125284 http://fdaweb.com/login.php?sa=v&aid=D5125283 AdvaMed recommends ways FDA might improve communication with industry on regulatory expectations. Tue, 21 May 2013 13:17:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125283 http://fdaweb.com/login.php?sa=v&aid=D5125282 Nine stakeholders ask FDA for additional information and changes in a draft guidance on pediatric information in drug and biological product labeling. Tue, 21 May 2013 11:43:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125282 http://fdaweb.com/login.php?sa=v&aid=D5125281 FDA plans to publish 5/22 a Final Rule approving two generic animal drugs. Tue, 21 May 2013 11:36:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125281