Drugs
FDA has issued a Warning Letter to Amgen over a promotional video for its colorectal cancer drug Vectibix (panitumumab) because it omitted all safety information and failed to disclose important limitations on the drug’s approved uses. In the just-posted 8/12 Warning Letter, CDER’s Office of Prescription
Drugs
A federal judge has denied Novo Nordisk’s request for a preliminary injunction blocking Eli Lilly from running allegedly misleading advertisements comparing its GLP-1 drugs Zepbound and Mounjaro with Novo’s Wegovy and Ozempic, finding that Novo failed to demonstrate irreparable harm. In a 10/26 opinion, U.S.
enforcement
FDA published another 79 Form 483 inspection records on 10/26 through the Office of Inspections and Investigations FOIA Electronic Reading Room, continuing a series of substantial disclosures of previously unavailable inspection documents. Their availability is part of the agency’s expanded transparency initiative (see earlier story), but a significant
Devices
AdvaMed is asking FDA to build on its existing regulatory framework for generative AI (GenAI)-enabled medical devices instead of creating new frameworks that could hinder innovation. In comments responding to an FDA discussion paper, AdvaMed said utilizing GenAI in medical devices “should not fundamentally alter the core principles that
enforcement
FDA has released the 10-page Form FDA-483 issued following a 6/10-6/19 inspection at the Eugia Steriles Private Limited sterile drug product manufacturing facility in Andhra Pradesh, India. The five inspection observations were: * failure to establish and follow written procedures designed to prevent microbiological contamination of
enforcement
FDA has released the Form FDA-483 issued following a 2/19-2/27 inspection at the GSK Vaccines licensed biological drug manufacturing unit in Marburg, Hassia, Germany. The two inspection observations were: * failure to validate the cleaning procedures for dedicated equipment used in the manufacture of aluminum hydroxide adjuvant
Biologics
FDA has posted a draft guidance outlining a regulatory framework that would allow manufacturers of individualized genome-editing (GE) therapies to include multiple patient-specific treatment variants in a single BLA and add additional variants after approval without necessarily conducting new clinical trials. The draft guidance, Individualized Human Genome Editing
Drugs
A 5/26-5/29 FDA inspection at the Northland Nuclear Medicine drug manufacturing facility in Bismarck, ND, found repeat current good manufacturing practice (CGMP) violations in the firm’s production of positron emission tomography (PET) drugs. A 10/22 Warning Letter says the firm’s PET drugs are adulterated
Drugs
An FDA review of records requested from Sanrace Biotechnology Co. in Zhejiang Province, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/22 Warning Letter says the specific violations were: * failure to conduct at least one test to verify the identity of each
Drugs
Failures to establish or follow written quality procedures and inadequate investigations of manufacturing problems were the most frequently cited deficiencies in FDA drug-quality inspections conducted during 2026, according to an FDA Webview analysis of agency inspection data. FDA cited deficiencies involving written quality-unit procedures in 74 inspections, representing
Independent news and analysis of FDA regulation, policy and enforcement
Risk-management deficiencies and inadequate corrective action procedures were the most frequently recorded problems in FDA medical device inspections conducted under the agency's new Quality Management System Regulation (QMSR), according to an FDA Webview analysis of 2026 inspection data. FDA cited failures to document risk-management processes associated
FDA has begun releasing large batches of Form FDA-483 inspection reports under its expanded transparency initiative (see earlier story), but a significant limitation in the agency's online FOIA Electronic Reading Room makes it difficult for users to identify newly posted documents: the database does not allow records
Brand-name and generic drug manufacturers are urging FDA to revise its proposed guidance (see earlier story) on determining whether sponsors should submit an ANDAor a 505(b)(2) application, with the two industry groups emphasizing different concerns about the agency's interpretation of the approval pathways. In separate
As the Trump administration considers an interim policy allowing compounding pharmacies to produce certain unapproved peptides, a public health advocacy group is warning that expanding access to the substances could undermine FDA's drug approval process and expose consumers to potentially unsafe products. The potential policy follows a July
FDA has accepted for priority review a Merck BLA for sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed antibody-drug conjugate (ADC), for adults with endometrial cancer previously treated with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor, administered separately or in combination. The agency has set
FDA's recent Warning Letter to O.N. Diagnostics raises questions about whether the agency is applying an overly expansive interpretation of when software modifications require a new 510(k), according to a new legal analysis. In a 10/26 FDA Law Blog article, attorney Jennifer Newberger examines the
FDA has approved AbbVie’s subcutaneous (SC) induction regimen for Skyrizi (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease (CD). “Patients now have the option to start SKYRIZI treatment at home, with induction doses delivered by an on-body injector (OBI) induction pack and then
BreakBio, a biotechnology company developing personalized cancer immunotherapies, has appointed former FDA Commissioner Stephen M. Hahn, who led the agency from 12/2019 to 1/2021 during the first Trump Administration, as an advisor. The company says Hahn will advise BreakBio on clinical development, regulatory strategy, oncology, platform development and
FDA has accelerated the public release of Form FDA-483 inspection records as part of its expanded transparency initiative (see earlier story), increasing the volume of inspection documents available through the agency's FOIA Electronic Reading Room. On 10/23, the agency published 26 Form FDA-483 records covering
A citizen petition filed by Foley & Lardner urges FDA to require mandatory monthly immunoglobulin monitoring and explicit treatment-interruption instructions in the prescribing information for Vertex Pharmaceuticals' investigational IgA nephropathy treatment povetacicept, ahead of an 11/30 user fee review action target date. The 10/21 petition contends
Bristol Myers Squibb reported preliminary safety and efficacy data from a Phase 1 study of its investigational CAR T-cell therapy zolacabtagene autoleucel (zola-cel; BMS-986353) in patients with multiple sclerosis, but disclosed that one trial participant died of septic pneumonia 44 days after receiving treatment. The death reportedly
If vaccine advocates gain substantial support in Congress following next month’s midterm elections, the Trump administration could still accelerate changes to federal vaccine policies in 2027, potentially limiting the effectiveness of congressional oversight, two former federal health policy officials warn. In a 10/20 MedPage Today commentary, Steven Grossman,