FDA Policy/General
Now that president Donald Trump has officially nominated White House health policy adviser Heidi Overton to become FDA commissioner, a quick Senate confirmation appears unlikely. In an 8/19 Truth Social post, Trump characterized Overton as a “rockstar” in the administration, “where she has worked directly with Secretary Kennedy, Dr.
Drugs
A 1/13-1/30 FDA inspection at the Safrel Pharmaceuticals drug manufacturing facility in Dayton, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/7 Warning Letter says Safrel failed to establish an adequate quality unit and to have in writing and
Drugs
FDA has granted Ultragenyx Pharmaceutical accelerated approval for its Genglycos (pariglasgene brecaparvovec-opnr) for adults and children eight years and older with glycogen storage disease type Ia (GSDIa). The action marks the first gene therapy approval for Ultragenyx and the company’s fifth FDA approval overall. Ultragenyx also received an
Drugs
FDA has issued a complete response letter to Xspray Pharma for its NDA for Dasynoc (dasatinib), the company’s product candidate to treat chronic myeloid leukemia and acute lymphoblastic leukemia. A company statement says the FDA letter relates to the agency’s previously communicated observations about CGMP issues at NerPharMa,
Drugs
A 3/2-3/5 FDA inspection at the Suretec Innovations drug manufacturing facility in Gilbert, AZ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/13 Warning Letter says the four specific violations were: * failure to test samples of each component for identity
Drugs
FDA has accepted for review a Teva Pharmaceuticals NDA for ecopipam, a company-described first-in-class investigational therapy for treating pediatric patients with Tourette syndrome. If approved, the drug would become the first new treatment option indicated for pediatric patients with Tourette’s in more than 10 years and
Devices
FDA has granted Vitestro a de novo authorization for Aletta, the first standalone robotic device designed to draw blood from a patient’s arm without hands-on intervention by a phlebotomist. The device is authorized for use in adults in outpatient settings and must operate under the supervision of a
Biologics
FDA has published a guidance, Frequently Asked Questions—Developing Potential Cellular and Gene Therapy Products, to help facilitate the development of safe, effective, and high-quality cellular and gene therapy (CGT) products. The document contains common questions directed to FDA and spans multiple disciplines, including regulatory review; chemistry, manufacturing, and
Drugs
A 2/4-2/6 FDA inspection at the Auriga Research contract testing laboratory in Bengaluru, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/12 Warning Letter says the specific violations were: * failure to ensure that laboratory records included complete data derived
Drugs
Merck and Moderna say the Phase 3 INTerpath-001 trial of Keytruda (pembrolizumab) plus intismeran autogene (intismeran; V940 or mRNA-4157) met the endpoints of recurrence-free survival and distant metastasis-free survival in patients with completely resected stage IIB-IV melanoma. A Merck statement says the results are the
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