FDA Policy/General

Latest Federal Register Notices

Meeting on Asbestos in Talc and Cosmetic Products
Federal Register notice: FDA announces a 2/4 public meeting entitled “Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc.” 01/10/2020

FDA Withdrawing 249 ANDAs Over Annual Reports
Federal Register notice: FDA proposes to withdraw approval of 249 ANDAs from multiple companies because they have repeatedly failed to file required annual reports. 01/09/2020

Info Collection on Tissue Transplantation
Federal Register notice: FDA submits to OMB an information collection extension for “Human Tissue Intended for Transplantation — 21 CFR Part 1270.” 01/09/2020

Info Collection on Administrative Practice/Procedures
Federal Register notice: FDA seeks comments on an information collection revision for “General Administrative Practice and Procedures.” 01/09/2020

Public Meeting on Modernizing FDA Data Strategy
Federal Register notice: FDA announces a 3/27 public meeting entitled “Modernizing FDA’s Data Strategy.” 01/08/2020

Comments Extended on Certificates of Confidentiality Guide
Federal Register notice: FDA extends until 1/24 the comment period for a draft guidance entitled “Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.” 01/08/2020

FDA Focus Group Info Collection Extension
Federal Register notice: FDA seeks comments on an information collection extension on “Focus Groups as Used by the Food and Drug Administration (All FDA-Regulated Products).” 01/08/2020

Comments Extended on Homeopathic Drug Guide
Federal Register notice: FDA extends until 3/23 the comment period on a revised draft guidance entitled “Drug Products Labeled as Homeopathic.” 01/08/2020

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