FDA Policy/General

Latest Federal Register Notices

Notice Corrected on Drug Development Tools Guide
Federal Register notice: FDA is correcting an 11/25 notice entitled Qualification Process for Drug Development Tools; Guidance for Industry. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section, and this notice corrects the error. To view the notice, click here. 12/11/2020

FDA Withdraws 10 No-Longer-Marketed ANDAs
Federal Register notice: FDA is withdrawing approval of 10 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. The applicants also waived their opportunity for a hearing. To view the notice, click here. 12/11/2020

Comments Extended on Electromagnetic Compatibility Guide
Federal Register notice: FDA has extended the comment period on a draft guidance entitled Electromagnetic Compatibility of Medical Devices. Electronic or written comments can be submitted until 2/16/2021. To view the notice, click here. 12/11/2020

Bone, Reproductive/Urologic Drugs Panel Renewed
Federal Register notice: FDA has announced the renewal of its Bone, Reproductive and Urologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 3/23/2022. To view the notice, click here. 12/10/2020

FDA Withdrawing Approval of Allergan’s Asacol
Federal Register notice: FDA is withdrawing the approval of an Allergan Pharmaceuticals International NDA for Asacol (mesalamine) delayed-release tablets, 400 mg. The withdrawal decision is based on FDA concerns about certain phthalate esters, including dibutyl phthalate (DBP), being developmental and reproductive toxicants in laboratory animals. Asacol (mesalamine) contains DBP as an inactive ingredient and FDA told the company in 2017 that the product presents a potential problem. Allergan has agreed to the withdrawal and waived its opportunity for a hearing. To view the notice, click here. 12/10/2020

FDA Performance Review Board Members Announced
Federal Register notice: FDA has announced the names of the members who will serve on its fiscal year 2020 Performance Review Board. The board is intended to provide fair and impartial review of staff’s Senior Executive Service, Senior Professional, 21st Century Cures Act, and Title 42(f) performance appraisals, bonus recommendations, and pay adjustments. To view the notice, click here. 12/10/2020

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