FDA Policy/General

Latest Federal Register Notices

Diabetes Device Feasibility Studies Guidance
05/06/2022 Federal Register notice: FDA has made available a final guidance entitled “Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus.” The document’s scope applies to devices such as neurostimulators, and those that mimic or result in anatomical changes similar to those made by bariatric surgical procedures, alter the anatomy and/or physiology of the small intestines, or manipulate the sympathetic nervous system. To view the notice, click here.

Guide on Radiolabeled Mass Balance Studies
05/05/2022 Federal Register notice: FDA has made available a draft guidance entitled “Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies.” The document describes agency recommendations on deciding whether and when to conduct such studies, study designs, and reporting results. To view the notice, click here.

Anesthetic/Analgesic Drugs Panel Renewal
05/04/2022 Federal Register notice: FDA has announced its renewal of the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/1/2024. To view the notice, click here.

Marqibo Accelerated Approval Withdrawn
05/02/2022 Federal Register notice: FDA is withdrawing the accelerated approval of Acrotech Biopharma’s NDA for Marqibo (vincristine sulfate liposome injection), indicated for treating certain adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia. The company requested the withdrawal due to agency concerns that a postmarketing trial required to verify clinical benefit had not been completed, and patient recruitment to fulfill the requirement appeared to be significantly challenging due to the treatment options that are currently available. To view the notice, click here.

Regeneron Awarded Priority Review Voucher
05/02/2022 Federal Register notice: FDA has issued Regeneron Pharmaceuticals a priority review voucher under its material threat medical countermeasure product program. The voucher was awarded after FDA determined that Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), indicated for treating infections caused by Zaire ebolavirus, met the program’s criteria. To view the notice, click here.

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