FDA Policy/General

Latest Federal Register Notices

Joint Panel to Review Nektar Back Pain Drug
Federal Register notice: FDA announces a 1/14/2020 Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee joint meeting to discuss a Nektar Therapeutics drug. 12/06/2019

Review Period for Biomarin’s Palynziq
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Biomarin Pharmaceutical’s Palynziq (pegvaliase-pqpz). 12/06/2019

2 Pain Drug NDAs Head to Panel
Federal Register notice: FDA announces a 1/15/2020 Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee joint meeting to discuss two pain NDA submissions. 12/06/2019

Dietary Supplement GMPs Info Collection
Federal Register notice: FDA is seeking comments on an information collection revision for Dietary Supplements good manufacturing practices. 12/05/2019

Cell/Tissue Product Registration Info Collection
Federal Register notice: FDA seeks comments on an information collection extension for “Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing.” 12/05/2019

Nonvoting Device Industry Reps for Panels Sought
Federal Register notice: FDA requests that any industry organizations interested in participating in selecting nonvoting industry representatives to serve on certain Medical Devices Advisory Committee panels notify the agency in writing. 12/05/2019

Guide on Interstitial Cystitis/Bladder Pain Syndrome
Federal Register notice: FDA makes available a draft guidance entitled “Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment.” 12/05/2019

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