Drugs

Latest Federal Register Notices

Nizoral Not Withdrawn Due to Safety/Effectiveness: FDA
Federal Register notice: FDA determines that Janssen Research & Development“ Nizoral (ketoconazole) tablets, 200 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. 09/01/2017

Guide on Medical Device Panel Meetings
Federal Register notice: FDA announces the availability of a guidance entitled “Procedures for Meetings of the Medical Devices Advisory Committee.” 09/01/2017

FDA Ending Support of Earlier Data Tabulation Model
Federal Register notice: FDA announces the end of support for Version 1.2 of Clinical Data Interchange Standards Consortium Study Data Tabulation Model (SDTM) and an update to the FDA Data Standards Catalog. 09/01/2017

FDA Updates MedDra Medical Dictionary Recognition
Federal Register notice: FDA announces support for the most current version of the Medical Dictionary for Regulatory Activities, and it ends support for previous versions. 08/31/2017

Cenestin Not Withdrawn Over Safety/Effectiveness: FDA
Federal Register notice: FDA determines that Teva’s Cenestin (estrogens, conjugated synthetic A) tablets, 0.3 milligrams (mg), 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. 08/31/2017

Draft Guide on Generic Digoxin Tablets
Federal Register notice: FDA makes available a draft revised guidance for industry on generic digoxin tablets. 08/30/2017

FDA Withdraws Approval of Upsher-Smith’s Propranolol HCl
Federal Register notice: FDA announces that it is withdrawing approval of an Upsher-Smith Laboratories ANDA for propranolol hydrochloride extended-release capsules due to concerns about the validity of bioequivalence data. 08/30/2017

Device User Fee Rates for FY 2018
Federal Register notice: FDA announces medical device user fee rates and payment procedures for fiscal year 2018. 08/29/2017

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome