Drugs
FDA has extended by three months its review of an Agios Pharmaceuticals supplemental NDA for mitapivat, an oral pyruvate kinase (PK) activator, for treating sickle cell disease. The user fee review action target date is now 2/1/2027. The company says FDA recently requested additional information to evaluate whether
Devices
Drugs
FDA has approved revised labeling for three additional estradiol transdermal patch products, removing boxed-warning statements about cardiovascular disease, breast cancer and probable dementia, HHS announced 10/30, prompting renewed criticism over the agency's decision to proceed without a formal advisory committee meeting or publicly presenting detailed scientific
FDA Policy/General
The American Medical Association (AMA) is urging FDA to “uphold rigorous, evidence-based standards for evaluating botanical drug products,” warning that products marketed with unproven health claims can pose serious risks when their safety and efficacy have not been established. In comments to FDA, the AMA emphasized that botanical products
Biologics
CBER’s Advertising and Promotional Labeling Branch (APLB) is warning biologic marketers against using progression-free survival and overall survival data from single-arm studies to support promotional claims that cannot be substantiated by the underlying clinical evidence. Speaking at a 10/28 Food and Drug Law Institute advertising and
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) issued 30 enforcement letters during fiscal year 2026, including 28 untitled letters and two warning letters, according to office director Twyla Mosey, who told a Food and Drug Law Institute conference that many promotional violations might have been avoided if drugmakers had
Drugs
FDA has posted an International Council for Harmonization revised final guidance to clarify how drug developers should evaluate the potential for investigational drugs to prolong the QT/QTc interval and cause potentially serious cardiac arrhythmias, including circumstances in which traditional clinical cardiac safety studies may not be feasible. The guidance,
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
Independent news and analysis of FDA regulation, policy and enforcement
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
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
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
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
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
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
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
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