FDA Policy/General

Latest Federal Register Notices

Regulatory Review Period for Edwards Aortic Valve
Federal Register notice: FDA determines that the regulatory review period for Edwards Lifesciences’ Edwards Intuity Elite Aortic Valve is 1,508 days. 05/24/2019

Final Guide on Compounding Bulks List
Federal Register notice: FDA makes available a final guidance entitled “Section 503A Bulks List Final Rule Questions and Answers.” 05/24/2019

General Surgery Device Panel Meeting Amended
Federal Register notice: FDA announces an amendment to a 4/24 Federal Register notice about a 5/30-31 General and Plastic Surgery Devices Panel meeting. 05/23/2019

Therapeutic Protein Biosimilars Draft Guide
Federal Register notice: FDA posts a draft guidance on “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” 05/22/2019

24 No-Longer-Marketed ANDAs Withdrawn
Federal Register notice: FDA withdraws approval of 24 ANDAs from multiple applicants. 05/22/2019

Info Collection Extension for Exports: Notification and Recordkeeping
Federal Register notice: FDA submits to OMB an information collection extension for “Exports: Notification and Recordkeeping Requirements — 21 CFR 1.101.” 05/20/2019

FDA Reorganizes Headquarters Organizations and Product Centers
Federal Register notice: FDA announces it has modified organizational structures in the Office of the Commissioner, headquarters organizations, and product Centers. 05/20/2019

Info Collection Extension for Drug Patent Listings
Federal Register notice: FDA seeks comments on an information collection extension for “Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements.” 05/17/2019

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