FDA Policy/General

Latest Federal Register Notices

Joint Panel to Discuss Celebrex Safety Data
Federal Register notice: FDA announces a 4/24-25 joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting to discuss Celebrex safety v. ibuprofen or naproxen. 03/30/2018

Workshop on Generic Regulatory Science Initiatives
Federal Register notice: FDA announces a 5/24 public workshop on “FY 2018 Generic Drug Regulatory Science Initiatives.” 03/30/2018

Joint Advisory Panel to Meet on Pain Drug NDA
Federal Register notice: FDA announces a 5/22 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee advisory committee meeting. 03/30/2018

Revised Draft Guide for Generic Doxycycline Hyclate
Federal Register notice: FDA makes available a revised draft guidance on generic doxycycline hyclate oral delayed-release tablets, entitled “Product-Specific Guidance for Doxycycline Hyclate.” 03/29/2018

New Info Collection Sought for Drug Compounding Guide
Federal Register notice: FDA seeks OMB approval for a new information collection entitled “Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” 03/29/2018

Organization Change to CDER Regulatory Policy Office
Federal Register Final Rule; technical amendment: FDA amends its regulations to reflect an organizational change for CDER’s Office of Regulatory Policy. 03/28/2018

Gastrointestinal Drugs Advisory Committee Charter Extended
Federal Register notice: FDA renews for an additional two years the charter for its Gastrointestinal Drugs Advisory Committee. 03/28/2018

FDA Joint Panel to Review InfaCare Pharma NDA
Federal Register notice: FDA announces a 5/3 joint Gastrointestinal Drugs Advisory Committee and Pediatric Advisory Committee meeting. 03/28/2018

Compounding Committee Seeks Member Nominations
Federal Register notice: FDA requests nominations for members to serve on its Pharmacy Compounding Advisory Committee. 03/27/2018

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