FDA Policy/General
A new Department of Justice directive identifying violations of the Federal Food, Drug, and Cosmetic Act (FDCA) among potential targets for fraud enforcement could expose FDA-regulated firms to increased federal investigations and criminal prosecutions, according to an analysis by attorneys at Holland & Knight. The 10/1 directive outlines
Biologics
FDA has released a final guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products — Questions and Answers.” The document explains how manufacturers should document and report changes to approved biosimilars, including changes involving manufacturing processes, production facilities, dosage forms and strengths. Regarding information required for postapproval manufacturing changes,
Devices
Drugs
U.S. representative Josh Gottheimer (D-NJ) and thirty-eight of his colleagues sent a bipartisan letter to HHS and FDA urging them to establish clear, consistent standards for defining rare disease patient populations. The lawmaker is the founder and co-chair of the Congressional Sarcoidosis Caucus. “When 95% of
Biologics
FDA has posted a final guidance entitled “Questions and Answers on Biosimilar Development and the BPCI Act.” The document provides answers to common questions from prospective applicants and other interested parties regarding section 351(k) of the Public Health Service Act, which was added by the Biologics Price Competition and
Drugs
FDA has cited four deaths among patients treated with Newron Pharmaceuticals’ investigational schizophrenia drug evenamide as a potential cardiac safety signal, according to new details disclosed by the company concerning the agency's continuing clinical hold on its Phase 3 ENIGMA-TRS 2 study in the U.S. A
Biologics
Rep. Nick Langworthy (R-NY) has introduced the Biosimilars Access and Affordability Act, bipartisan legislation that he says would expand access to lower-cost biosimilar prescription drugs and help bring them to market. In a statement, Langworthy says the bill would update Medicare policy to provide a clearer pathway for
Biologics
HHS says it is taking a series of actions to “strengthen how the federal government identifies, documents, investigates, and responds to health problems reported following vaccination, with a focus on improving patient care and generating better evidence about potential vaccine-related injuries.” A department statement says HHS: * opened a National
Drugs
FDA has released a final guidance entitled “Study Data Technical Conformance Guide - Technical Specifications Document” that provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog. The document supplements the guidance “Providing Regulatory Submissions in
Biologics
Three stakeholders have submitted general and specific comments to FDA on the agency’s draft guidance on considerations for container closure and device constituent parts for biosimilar and interchangeable biosimilar products. The Biosimilars Forum comment letter made these general points: * other tools, including qualitative human factor studies, effectively evaluate user
Independent news and analysis of FDA regulation, policy and enforcement
FDA has approved Genentech’s Tecentriq (atezolizumab) for combination use with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cancer. The agency also approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) in
Ascendis Pharma is petitioning FDA to require additional information sufficient to evaluate unresolved safety questions before approving infigratinib to treat children with achondroplasia. The company’s 10/6 petition asks specifically that FDA: * include internal neurodevelopmental experts on the review team to consider the risks infigratinib’s mechanism of action
Ultragenyx Pharmaceutical has agreed to sell its Rare Pediatric Disease Priority Review Voucher to an undisclosed buyer for $210 million. FDA awarded the voucher in August upon approval of Genglycos (pariglasgene brecaparvovec-opnr), also known as DTX401, for use in adult and pediatric patients eight years and older with glycogen
A new Stanford Biodesign policy paper is calling for a dozen bipartisan FDA reforms aimed at accelerating clinical trials and drug reviews, including allowing some lower-risk Phase 1 trials to begin without waiting for prior FDA approval and expanding rolling review of marketing applications. The paper, Roadmap for FDA
FDA has warned O.N. Diagnostics that it made significant changes to its VirtuOst vertebral fracture assessment software — including a new machine-learning algorithm and conversion to a web-based platform — without obtaining required agency clearance. A just-posted 9/1 Warning Letter following a March inspection of the Berkeley,
MimiVax says it plans to seek a meeting with FDA to review positive results from its Phase 2b SURVIVE trial of SurVaxM, a novel cancer vaccine for patients with newly diagnosed glioblastoma. In a statement, company officials say they want to use the meeting to review the SURVIVE data and
Biostatisticians from FDA and several universities say interest in integrating randomized clinical trials (RCTs) with real-world data (RWD) continues to grow as stakeholders seek evidence that is both internally valid and relevant to clinical practice. Writing in an open-source article in Clinical Pharmacology & Therapeutics, the researchers say,
FDA says that as of 10/7, there are 159 medical devices enrolled in the Total Product Life Cycle Advisory Program (TAP) pilot. An online update also says that on 7/1, TAP expanded to accept enrollment requests across all Offices of Health Technologies for Breakthrough-designated and Safer Technologies
FDA and the National Institutes of Health (NIH) are “working together extremely closely” in the effort to reduce animal testing for drugs. That’s the report of NIH deputy director for program coordination, planning, and strategic initiatives Nicole Kleinstreuer, who said, “I think what we’re seeing is an unprecedented
A review of 42,192 observations from 8,663 inspections conducted between 2008 and 2026, as shown on the FDA inspection dashboard, found that 2026 does not represent a wholesale shift in FDA inspection priorities. Rather, according to regulatory consultant Jeffrey Palmer, writing in an online post, it reflects intensified
FDA’s decision to establish its new Office of Innovation and Clinical Trial Modernization (OICTM) and form dedicated divisions for artificial intelligence (AI) and real-world evidence (RWE) analytics (see earlier story) could provide drug developers with a clearer regulatory pathway for emerging technologies, but the agency now faces the
A 3/9-3/16 FDA inspection at the TCI Co., Ltd BioCosme PABP Branch drug manufacturing facility in Taipei City, Taiwan, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 9/2 Warning Letter says the four specific violations were: * failure to