Drugs
An FDA 1/20-2/13 inspection at the K.C. Pharmaceuticals drug manufacturing facility in Pomona, CA, found repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/12 Warning Letter says the specific violations were: * failure to establish and follow appropriate written procedures
Biologics
FDA has issued a draft guidance that outlines recommendations for developing potency assays for active immunotherapy products (ACTIMPs), including personalized cancer immunotherapies, vectored products and cell-based therapies. The document, “Potency Assessment of Active Immunotherapy Products,” is intended to provide a science- and risk-based framework for evaluating whether ACTIMPs
Drugs
FDA has approved Regneron’s Pasatru (garetosmab-grts) for reducing new heterotopic ossification (bone formation outside the skeleton) and reduce clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva (FOP), a rare genetic disease caused by a mutation in activin A receptor-type 1, which controls new bone
Devices
A systematic analysis conducted by university researchers around the world of all FDA-cleared artificial intelligence/machine learning-enabled medical devices through 12/5/2025 highlights a “profound validation gap” and the need for evidence standards capable of keeping pace with the speed of regulatory clearance. Writing in the open-
Drugs
A 2/16-2/27 FDA inspection at the Eugia Pharma drug manufacturing facility in Kolthur Village, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/13 Warning Letter says the specific violations were: * failure to perform operations within specifically defined areas of
FDA Policy/General
President Donald Trump has selected White House health policy adviser Heidi Overton as his nominee to become FDA commissioner, according to multiple media reports. If confirmed by the Senate, Overton would succeed former commissioner Marty Makary, who resigned in May. Overton currently serves as deputy director of the White House
Drugs
FDA has cited Neeyaan LLC for multiple GMP deficiencies, including the firm’s failure to validate drug manufacturing processes, conduct cleaning validation and adequately test incoming raw materials. In a just-posted untitled letter, FDA said the company failed to establish and follow adequate written procedures for production and process
Devices
Mosaic Clinical Technologies is petitioning FDA to clarify the regulatory status of commercially available artificial intelligence vision language models (VLMs). The petition says VLMs perform medical image analysis to support diagnosis and treatment and ensure consistent application of medical device requirements to these tools. “The safety and effectiveness of these
Devices
FDA is soliciting stakeholder feedback on a discussion paper outlining considerations for regulating AI-enabled medical devices. The paper says generative artificial intelligence (GenAI)-enabled medical devices “hold transformative promise for patient care and the broader health ecosystem.” It also says such devices may introduce unique risks when compared to
Drugs
FDA’s review of records it requested from Tianjin Kilo Pharmaceutical Sci-tech Co. in Tianjin Shi, China, found four significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). An 8/6 Warning Letter says the specific deviations were: * failure to demonstrate that the company’
Drugs
McGuireWoods partner Clint Narver is leaving the law practice to rejoin FDA as director of the Office of Compounding Quality and Compliance (OCQC). His final day at the firm will be 8/21. OCQC develops and implements federal drug compounding policy, oversees pharmacy compounders and outsourcing facilities nationwide, and runs
Drugs
Amylyx Pharmaceuticals says it will file an NDA by the end of the year for its investigational drug avexitide after new data show significantly reduced hypoglycemic events in a Phase 3 clinical trial involving patients with post-bariatric hypoglycemia (PBH).The company just reported topline results from the 78-participant
Drugs
Valisure has sued the United States Pharmacopeia (USP), accusing the standards-setting organization of making false and misleading statements about the laboratory's methods for detecting potentially harmful impurities in medicines. The lawsuit centers on a 2023 USP white paper titled Unvalidated Methods for Medicine Quality Testing Can Lead
Drugs
FDA has issued a draft revised guidance intended to help drug developers determine whether a proposed product should be submitted through the ANDA pathway under Section 505(j) of the Federal Food, Drug, and Cosmetic Act or through the 505(b)(2) NDA pathway. The document, Determining Whether to Submit
Drugs
As Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., European regulators have recommended the revocation of the drug’s marketing authorization, according to a document outlining concerns. Last month, Amgen submitted to FDA new scientific data and analyses as part of its formal
Drugs
Regeneron Pharmaceuticals has stopped a Phase 1/2a clinical trial of experimental anti-CD3 monoclonal antibody REGN7041 in patients with noninfectious uveitis after a safety event prompted the company to reassess the drug's risk-benefit profile, according to a clinicaltrials.gov posting. Regeneron said the decision to terminate
Biologics
Two Republican senators have released a 5/2021 email from then-acting FDA commissioner Janet Woodcock in which she raised concerns about reports of unexplained adverse events that appeared following Covid-19 vaccination and urged federal health officials to consider conducting a study. Sens. Ron Johnson (R-WI) and Rand
Drugs
FDA is announcing a 9/9 meeting with the Reagan-Udall Foundation for the FDA to hear public comments on perspectives involving opioid medication use for managing pain and addiction. The meeting will also feature a panel discussion with federal partners to discuss efforts to improve the pain management and
Devices
Baxter is recalling (Class 1) certain lots of its Duo-Vent solution sets because the devices may allow air bubbles to enter the administration set during pressure infusion or flushing, potentially exposing patients to serious injury or death. The issue involves the potential formation of air bubbles in the drip
Drugs
FDA has approved Lantheus Holdings’ Tauklarify (florquinitau F 18 injection) as a PET imaging agent to identify tau neurofibrillary tangle pathology in adults with cognitive impairment being evaluated for Alzheimer’s disease. The approval covers use of the imaging agent, also known as MK-6240, for brain positron emission tomography
Drugs
FDA has granted OS Therapies a Type C statistical methods meeting with CBER to discuss 2.5-year overall survival data for OST-HER2, the company’s investigational immunotherapy for preventing or delaying recurrence in patients with fully resected, pulmonary metastatic osteosarcoma. OS Therapies says an interim three-year overall
Drugs
Last week’s accelerated approval of Replimune’s Tudriqev (vusolimogene oderparepvec-wtpg) came despite significant concerns about the reliability of efficacy results from the company’s Phase 1/2 IGNYTE trial. The genetically modified oncolytic viral therapy’s approval covers its use in combination with Bristol Myers Squibb's