Drugs
Former FDA principal deputy commissioner, acting commissioner, and CDER director Janet Woodcock says reforms are needed to make individualized gene therapies a viable development opportunity for rare diseases. Writing in a BioCentury online commentary, Woodcock says FDA already has the statutory authority to address several of the barriers preventing the
Drugs
Vanda Pharmaceuticals and FDA are asking a federal judge to resolve a dispute over the agency's partial clinical hold on a yearlong trial of tradipitant for gastroparesis, with the company arguing that FDA's insistence on additional animal toxicity testing violates the FDA Modernization Act 2.0
Devices
FDA has issued a revised a 6/2024 draft guidance outlining the performance characteristics manufacturers should evaluate, validate and control for medical devices used to deliver drugs and biological products, including drug-device combination products. The guidance, Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological
Devices
FDA has issued a Warning Letter to Utah-based Chirp Innovations LLC for promoting its cleared Halo Wireless Muscle Stimulator for menstrual pain without obtaining additional marketing clearance and for widespread deficiencies in its quality system and medical device reporting procedures. The 10/2 Warning Letter followed an 11/2025
Drugs
FDA has accepted for review a resubmitted NDA for Izipry (naloxone nasal powder), a high-dose naloxone rescue medication for opioid overdose. The agency has set a user fee review action target date of 3/29/2027. Izipry is being developed using Orexo’s proprietary AmorphOX powder-based drug delivery
Drugs
FDA has published an updated Concept of Operations outlining how CDER and the Office of Inspections and Investigations (OII) (formerly the Office of Regulatory Affairs) “collaborate in a coordinated, programmatically aligned environment regarding marketing application assessment, inspections, and related activities.” The document covers preapproval, postapproval, surveillance, and for-cause inspection
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
Independent news and analysis of FDA regulation, policy and enforcement
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
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
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
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
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
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
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