FDA Policy/General
Former senior HHS adviser Calley Means has accused FDA commissioner nominee Heidi Overton of pressuring former commissioner Marty Makary to approve Moderna's mRNA influenza vaccine despite his scientific objections, alleging that she conditioned assistance on other policy matters on his willingness to approve the product. Means resigned 10/
Devices
FDA has issued Novocure a Not Approvable Letter for its PMA for Optune Mya for treating adult patients with brain metastases from non-small cell lung cancer following stereotactic radiation. The said the agency determined that uncertainty around the degree of clinical benefit provided by Optune Mya prevented approval, according
enforcement
FDA has posted 20 Form 483 inspection records (see below), including reports involving Novo Nordisk, AnaptysBio, Protagonist Therapeutics, Ascendis Pharma and Charles River Laboratories, as the agency continues expanding public access to inspection findings through its electronic reading room. Their availability is part of the agency’s expanded transparency initiative
FDA Policy/General
Democratic control of Congress following the 11/3 midterm elections could bring increased oversight of FDA and HHS, complicate the nomination of a permanent FDA commissioner and turn the 2027 user fee reauthorization into a vehicle for broader health policy legislation, according to FDA policy analyst and former HHS official
Drugs
FDA is requiring manufacturers of all glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs to add warnings about a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that can cause sudden, permanent vision loss. NAION typically causes acute, painless vision loss
Drugs
Boehringer Ingelheim says it will seek global approvals for survodutide, which it describes as the first glucagon/GLP-1 dual agonist to demonstrate a favorable cardiovascular safety profile in a Phase 3 trial alongside significant cardiometabolic benefits. The company says its SYNCHRONIZE-CVOT trial met its primary endpoint using both
Devices
FDA is seeking public input on how to evaluate the benefits and risks of medical robots capable of performing tasks autonomously or being operated remotely, as advances in artificial intelligence and connectivity expand their potential clinical applications. In a just-posted discussion paper, CDRH identifies regulatory questions involving autonomous decision-
FDA Policy/General
More than 90% of public comments submitted during five FDA drug advisory committee reviews favored approval of the products under consideration, according to a new study examining public participation in the agency's regulatory decision-making process. The study, published 11/7 in Therapeutic Innovation & Regulatory Science, analyzed
Biologics
FDA is investigating the safety of Novartis’ Zolgensma, an adeno-associated virus (AAV) vector-based gene therapy for spinal muscular atrophy (SMA), based on postmarketing adverse event reports of malignancies in treated patients. The adverse events include confirmed reports of “product-related insertional oncogenesis involving the GLI1 (Glioma-Associated Oncogene
Drugs
Long-term clinical trial extension studies can provide important evidence about drug safety and durability of treatment effects, but their findings may be compromised by selection bias, patient attrition and the loss of randomized comparison groups, according to a 10/7 JAMA editorial. The editorial highlights a challenge for FDA
Independent news and analysis of FDA regulation, policy and enforcement
Chemistry, manufacturing and controls (CMC) concerns accounted for 58% of the topics raised in FDA information requests during reviews of seven adeno-associated virus (AAV) gene therapy applications, according to an analysis by agency scientists published 11/6 in Nature Reviews Drug Discovery. The analysis, conducted by CBER researchers, examined
As FDA moves to reduce animal testing requirements for certain drugs, researchers say emerging technologies involving human organoids, organ-on-a-chip systems and artificial intelligence could replace some traditional animal studies, although significant scientific and regulatory limitations remain. In a Perspective published 11/2 in The Innovation, researchers from
FDA officials remain confident that Congress will reauthorize the agency's four major user fee programs before they expire next September, although Democratic control of Congress and the prospect of Sen. Bernie Sanders (I-VT) chairing the Senate HELP Committee could complicate the reauthorization over the already-negotiated agreements.
Merck's investigational GLP-1/glucagon receptor dual agonist efinopegdutide (MK-6024) demonstrated higher rates of MASH resolution and liver fibrosis improvement than placebo in a Phase 2b trial involving patients with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced fibrosis. The results, presented at the American Association
FDA officials say drug manufacturers may be able to establish dosing recommendations and characterize drug-drug interaction risks without conducting additional clinical studies, including through pharmacokinetic modeling and real-world data, provided the evidence is scientifically justified. During a series of FDA presentations released 11/4 on [Drug Interaction Information
FDA has granted Janssen Biotech accelerated approval for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) and its use in treating adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. “HNSCC is an aggressive, life-threatening disease
FDA associate commissioner for inspections and investigations Elizabeth Miller says unannounced drug inspections in China and India increased significantly in FY 2026 compared with FY 2025 inspection numbers. As reported by the Regulatory Affairs Professional Society’s online Regulatory Focus newsletter, she spoke at the Association for Accessible Medicines’ GRx+
Yale School of Medicine researchers say there are steps FDA could take to improve the evaluation of elements in Risk Evaluation and Mitigation Strategies (REMS) programs. Writing in JAMA Internal Medicine, the researchers say REMS requirements intended to increase patient and prescriber knowledge of medication safety and risks include medication
FDA 11/5 posted five additional Form FDA-483 inspection reports, including four involving manufacturers in Japan and one involving a U.S. drug outsourcing facility. The newly published records cover inspections conducted between October 2023 and September 2026. They include: * LeeSar Inc., Florida: Inspection dated September 23, 2026, involving
FDA's drug and biologics review centers added a net 84 employees during the fourth quarter of fiscal year 2026, reversing earlier staffing losses but leaving their combined workforce about 18% below its level at the beginning of fiscal 2025, according to newly updated agency hiring data. The figures
Commenting on an Ascendis Pharma 10/6 petition asking FDA to require additional information about BridgeBio’s infigratinib to resolve safety questions involving its potential indication to treat children with achondroplasia, Center for Medicine in the Public Interest president Peter Pitts says FDA should be held to the same scientific
VivoSim Labs executive chairman Keith Murphy says that now that FDA has finalized a rule permitting non-animal methods for drug safety testing, it should move quickly to make a determination that some non-animal methods have already reached a well-qualified state that makes them supportive of the agency’