FDA Policy/General

Latest Federal Register Notices

FDA Amends Animal Drug Regs for Approvals
2/25/2022 Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for NADAs, ANADAs and conditionally approved NADAs made during 7/2021, 8/2021 and 9/2021. Additionally, the agency is informing the public about the availability of summaries of the basis of approval and of environmental review documents, where applicable. To view the notice, click here.

FDA Withdrawing 5 No-Longer-Marketed ANDAs
2/25/2022 Federal Register notice: FDA is withdrawing approval of five ANDAs from multiple applicants after they notified the agency that the drug products are no longer marketed and requested their withdrawal. To view the notice, click here.

Proposal to Harmonize Device QSR with ISO 13485
2/24/2022 Federal Register notice: FDA is publishing a proposed rule to amend medical device current GMP requirements of the Quality System Regulation to align more closely with the International Organization for Standardization’s 13485. It is also proposing additional requirements to clarify device GMP requirements for combination products. To view the notice, click here.

Meeting on Biosimilar User Fee Program Assessment
2/23/2022 Federal Register notice: FDA is announcing a 3/22 virtual public meeting entitled “Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act (BsUFA),” and an opportunity for public comment. The topics to be discussed are the final assessment and public stakeholder views about the program. 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