FDA Webview The leading publisher of FDA News, FDA Review, FDA Compliance, QSR News, and Food Drug Administration information since 1984. http://fdaweb.com/ Sun, 19 May 2013 00:43:16 -0500 Panel to Discuss Moxduo Opioid Drug Combo http://fdaweb.com/login.php?sa=v&aid=D5125258 Federal Register Notice: FDA's Anesthetic and Analgesic Drug Products Advisory Committee will meet 7/17 to discuss QrxPharma's NDA for Moxduo capsules for managing moderate to severe pain. Fri, 17 May 2013 11:41:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125258 Guidance on CDRH Appeals Process http://fdaweb.com/login.php?sa=v&aid=D5125257 Federal Register Notice: FDA releases a guidance describing the CDRH appeals processes. Fri, 17 May 2013 11:40:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125257 Guidance on CDRH Appeals Processes on Section 517A http://fdaweb.com/login.php?sa=v&aid=D5125256 Federal Register Notice: FDA releases a draft guidance: CDRH Appeals Processes: Questions and Answers About 517A. Fri, 17 May 2013 11:36:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125256 House Dems Introduce Clinical Trials Reporting Bill http://fdaweb.com/login.php?sa=v&aid=D5125255 Rep. Ed Markey (D-MA) and several other House Democrats introduce new legislation to take the errors out of clinical trial reporting. Fri, 17 May 2013 11:36:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125255 Pentec Recalls Compounded Therapies Due to Sterility Concerns http://fdaweb.com/login.php?sa=v&aid=D5125254 Pentec Health recalls its in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding. Fri, 17 May 2013 10:39:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125254 FDA OKs Direct Flow IDE for Transcatheter Aortic Heart Valve System http://fdaweb.com/login.php?sa=v&aid=D5125253 FDA approves a Direct Flow Medical IDE to begin the SALUS feasibility trial of its Transcatheter Aortic Heart Valve System. Fri, 17 May 2013 10:10:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125253 FDA Clears Oramed IND for Oral Insulin Capsule http://fdaweb.com/login.php?sa=v&aid=D5125252 FDA clears an Oramed Pharmaceuticals IND for ORMD-0801, an oral insulin capsule, indicated for the early stages of Type 2 diabetes. Fri, 17 May 2013 10:08:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125252 Companies Seek Changes to Post-approval Modifications Guidance http://fdaweb.com/login.php?sa=v&aid=D5125251 Companies urge FDA to make changes to its draft guidance on "Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA." Fri, 17 May 2013 09:21:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125251 FDA Approves Mylan's Generic Tricor http://fdaweb.com/login.php?sa=v&aid=D5125250 FDA approves a Mylan ANDA for fenofibrate tablets, 48 mg and 145 mg, a generic version of Abbvie's Tricor tablets. Fri, 17 May 2013 06:46:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125250 Thoratec HeartMate Pocket Controller Approved http://fdaweb.com/login.php?sa=v&aid=D5125249 Thoratec gains FDA approval to market the HeartMate I Pocket Controller for the HeartMate II Left Ventricular Assist Device (LVAD) System. Fri, 17 May 2013 05:05:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125249 Impax Launches Zomig Authorized Generic http://fdaweb.com/login.php?sa=v&aid=D5125248 Impax Laboratories launches an authorized generic of AstraZeneca's Zomig (zolmitriptan) tablets and orally disintegrating tablets. Fri, 17 May 2013 04:55:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125248 Concerns Raised on Product Design Draft Guidance http://fdaweb.com/login.php?sa=v&aid=D5125247 Concerns are raised by several stakeholders about FDA's draft guidance on product design to minimize medication errors. Thu, 16 May 2013 13:36:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125247 Public Citizen Criticizes HELP Committee Compounding Bill http://fdaweb.com/login.php?sa=v&aid=D5125246 Public Citizen says a Senate bill to regulate drug compounding by creating a new entity called compounding manufacturers would be a step backward for drug safety. Thu, 16 May 2013 12:38:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125246 Labeling Changes Approved for 48 Drug Products in April http://fdaweb.com/login.php?sa=v&aid=D5125245 FDA releases labeling changes approved for 48 drugs in April, including a new Boxed Warning for Boehringer Ingelheim's Pradaxa Thu, 16 May 2013 12:30:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125245 2 New and 8 Updated Medication Guides Out http://fdaweb.com/login.php?sa=v&aid=D5125244 FDA says new Medication Guides have been issued for two drugs and updated guides for eight other drugs. Thu, 16 May 2013 12:26:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125244 CDRH Releases 2 Draft Appeals Process Guidances http://fdaweb.com/login.php?sa=v&aid=D5125243 CDRH issues draft guidances on aspects of its process for appeals of Center actions and decisions. Thu, 16 May 2013 12:22:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125243 CBER Scientists Find Lung Injury Link to Irradiated Platelets http://fdaweb.com/login.php?sa=v&aid=D5125242 CBER researchers say their studies give a proof of concept that infusion of platelets damaged by UVB light may lead to sudden respiratory distress. Thu, 16 May 2013 12:19:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125242 FDA Not Changing Advertising Enforcement Post-Caronia http://fdaweb.com/login.php?sa=v&aid=D5125241 FDA says it has no plans to change its advertising and promotion enforcement approach in the wake of the recent Caronia court decision on First Amendment protections. Thu, 16 May 2013 11:26:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125241 Info on Bar Code Labels Sent to OMB http://fdaweb.com/login.php?sa=v&aid=D5125240 Thu, 16 May 2013 10:40:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125240 Comments Sought on Ruminant Feed Recordkeeping http://fdaweb.com/login.php?sa=v&aid=D5125238 Thu, 16 May 2013 10:39:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5125238