FDA Policy/General

Latest Federal Register Notices

FDA Seeks Industry Reps to Serve on Advisory Committees
Federal Register notice: FDA requests nominations for nonvoting industry representatives to serve on its public advisory committees for CDER. 02/08/2019

Info Collection Extension for Generic Drug Fee Coversheet
Federal Register notice: FDA submits to OMB an information collection extension for its “Generic Drug User Fee Coversheet.” 02/08/2019

Pilot Program on Drug Supply Chain
Federal Register notice: FDA announces the start of a pilot program under the Drug Supply Chain Security Act. 02/08/2019

Public Warnings on Recalls Guidance
Federal Register notice: FDA makes available a final guidance entitled “Public Warning and Notification of Recalls.” 02/08/2019

Guide on Depot Buprenorphine Product Development
Federal Register notice: FDA posts a final guidance entitled “Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment.” 02/08/2019

Pilot Program on Drug Supply Chain
Federal Register notice: FDA announces the start of a pilot program under the Drug Supply Chain Security Act. 02/08/2019

Panel to Review Karyopharm Multiple Myeloma Drug
Federal Register notice: FDA announces a 2/26 Oncologic Drugs Advisory Committee meeting to review a Karyopharm Therapeutics NDA for treating multiple myeloma. 02/07/2019

Eosinophilic Esophagitis Drug Development Guide
Federal Register notice: FDA makes available a draft guidance entitled “Eosinophilic Esophagitis: Developing Drugs for Treatment.” 02/07/2019

Guide on Combo Product Pathways
Federal Register notice: FDA makes available a draft guidance entitled “Principles of Premarket Pathways for Combination Products” that discusses how to determine which type of premarket submission is appropriate. 02/07/2019

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