enforcement
Medical device manufacturers increasingly using artificial intelligence (AI) for quality assurance and regulatory functions must maintain human oversight of those systems, according to former senior FDA officials who say the agency is also beginning to incorporate AI into its inspection and postmarket surveillance activities. Speaking on the 10/26 FDA
Drugs
A Duke Margolis Institute for Health Policy white paper, “From Research to Care: Modernizing U.S. Clinical Studies for Cures Into Care,” lists several priority actions that it says private organizations and collaborations need to take to reform the U.S. fragmented clinical research system. The report reviews the current
FDA Policy/General
HHS has announced an interim enforcement-discretion policy allowing state-licensed pharmacies, federal facilities and licensed physicians to compound six previously restricted peptides under specified conditions while FDA considers whether to formally authorize their use under Section 503A of the Federal Food, Drug, and Cosmetic Act. The 10/28 policy
Drugs
FDA’s recent final guidance Regulatory Considerations for Prescription Drug Use-Related Software provides sponsors with a “more concrete framework for navigating the boundary between FDA-required and promotional labeling, while placing a premium on early regulatory planning,” according to a new Akin legal analysis. The guidance outlines how prescription
Drugs
A 9/25 joint FDA/European Medicines Agency (EMA) workshop on “Regulatory Perspectives on Herbal Medicinal/Botanical Drug Development” set the stage for future joint activities in the herbal/botanical space, despite regulatory differences in the ways in which the two jurisdictions approach the products. An interview in an FDA
Devices
Commenting on an FDA proposal for classification of accessories distinct from other devices, including a proposed list of accessories suitable for Class 1, AdvaMed says that device specificity alone does not establish that general controls are insufficient. “Congress required FDA to classify each accessory based on its own risks, not
Drugs
Eli Lilly is reporting “positive topline results” from TRANSCEND-T2D-2, a head-to-head Phase 3 trial comparing retatrutide with Novo Nordisk’s injectable Ozempic 2 mg in adults with Type 2 diabetes. “At 80 weeks, retatrutide met the primary and all key secondary endpoints, delivering greater A1C reduction
enforcement
FDA published another 33 Form 483 inspection records on 10/27 through its Office of Inspections and Investigations FOIA Electronic Reading Room, including records involving Catalent, Janssen Biopharmaceuticals, Ferring Microbiome, Genzyme, Philips Medical Systems, Baxter and Grifols. Their availability is part of the agency’s expanded transparency initiative (see earlier
Devices
FDA has issued a draft guidance outlining plans to require IDE holders to use standardized electronic submission templates, extending the agency's electronic submission requirements to clinical investigations of medical devices. The guidance, Electronic Submission Template for Investigational Device Exemption (IDE) Applications, applies to IDE submissions reviewed by CDRH
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
Independent news and analysis of FDA regulation, policy and enforcement
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.
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
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
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
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
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
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
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
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
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