FDA Policy/General

Latest Federal Register Notices

Guidance on Combination Product Feedback
Federal Register notice: FDA makes available a final guidance entitled Requesting FDA Feedback on Combination Products.To view the notice, click here. 4/02/2021

Protective Barrier Enclosures, Infusion Pump EUAs Revoked
Federal Register notice: FDA is announcing the revocations of Emergency Use Authorizations (EUAs) issued to manufacturers of certain protective barrier enclosures and to manufacturers of certain infusion pumps and accessories. FDA revoked the protective barrier enclosures EUA on 8/20 after becoming aware of new preliminary evidence from simulated intubation procedure models of potential adverse events that could occur or complications with protective barrier enclosures without negative pressure recently reported in the literature. The infusion pump EUA was revoked 9/21 based on information and experience since issuance of the umbrella EUA, Instead of an umbrella EUA, FDA may issue individual authorizations for infusion pumps and infusion pump accessories that meet the requisite EUA statutory criteria. To view the notice, click here. 4/02/2021

Notice on Complex Generic Meetings Guidance Corrected
Federal Register notice: FDA has corrected an 11/25/2021 notice on a guidance entitled Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments. The notice 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. 4/01/2021

FDA Renews Pharmacy Compounding Advisory Panel
Federal Register notice: FDA has announced the renewal of its Pharmacy Compounding Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 4/25/2022. To view the notice, click here. 3/31/2021

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

Read more

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