FDA Policy/General
An analysis by two University of Southern California policy researchers finds that between 2013 and 2022, some 38% of FDA advisory committees included either a patient or consumer representative with active ties to an advocacy organization funded by a drug company. Writing in an open-source article for Project Hope,
FDA Policy/General
Former FDA regulatory counsel and now-partner at Spencer Fane Brian Malkin is questioning whether the agency should become more directly involved in the Trump administration's drug-pricing initiatives, raising concerns about the potential direction of FDA policy under commissioner nominee Heidi Overton, whose nomination remains pending in
Drugs
FDA researchers and academic collaborators identified nearly 80,000 prescription opioid-related cardiovascular adverse event signals in a large-scale analysis of the agency's Adverse Event Reporting System, suggesting that machine learning could improve postmarketing drug safety surveillance. The study, published September 28 in Frontiers in Drug Safety
Drugs
A 6/1-6/3 FDA inspection at the Eurofins SF Analytical Laboratories drug manufacturing facility in Horsham, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 10/6 Warning Letter says the three specific violations were: * failure to ensure that laboratory
Biologics
FDA has accepted for review a Formycon/Zydus Lifesciences BLA for FYB206, a biosimilar to Merck’s blockbuster cancer drug Keytruda (pembrolizumab). A statement says the biosimilar was developed without a comparative Phase 3 efficacy trial, following a development pathway agreed upon with FDA in early 2025. The companies say
Drugs
The Federal Trade Commission and seven states have asked a federal court to hold Martin Shkreli in civil contempt, alleging that he repeatedly violated a lifetime pharmaceutical industry ban by trading biotechnology stocks and attempting to influence drug companies. Shkreli, a former hedge fund manager and pharmaceutical executive, gained widespread
Biologics
Congressional Democrats are questioning the Trump administration's proposal to replace combination childhood vaccines with separate injections, a policy that could require new FDA regulatory reviews because single-disease measles, mumps and rubella vaccines are not currently available in the U.S. In a 10/7 letter to CDC
Devices
FDA has issued Olympus a 10/7 Warning Letter based on GMP issues raised during inspections of the firm’s facilities in the U.S., Japan, and Europe conducted in late 2025. The items in the Warning Letter primarily concern “aspects of the company’s quality management system and related
Drugs
A 4/16-4/24 FDA inspection at the Hanlim Pharm Co. drug manufacturing facility in Gyeonggi-do, South Korea, found violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 10/2 Warning Letter says the specific violations were: * failure to establish and follow appropriate
Drugs
An 11/3-11/7/2025 FDA inspection at the Jiangmen Shuizirun Sanitary Articles Co. drug manufacturing site in Jiangmen, Guangdong, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 9/23 Warning Letter lists the violations as: * failure to establish procedures
Independent news and analysis of FDA regulation, policy and enforcement
Elevar Therapeutics and China's Hengrui Pharmaceuticals have resubmitted a rivoceranib plus camrelizumab as a first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The companies’ resubmission marks the fourth attempt to win U.S. approval, and follows three previous complete response letters (CRLs) issued in
FDA granted approval to Revolution Medicines' Rasonque (daraxonrasib) for metastatic pancreatic cancer despite substantial differences in treatment responses among patients with different KRAS mutations and limited evidence of effectiveness in patients without RAS mutations, according to a newly released approval document. The 321-page review shows that FDA considered
The Trump Administration is developing a temporary policy that would allow compounding pharmacies to dispense certain unapproved peptides despite earlier FDA scientific assessments finding insufficient evidence of their safety and effectiveness, setting up a potential conflict between administration policy and the agency's scientific reviewers. Federal officials are considering
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
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,
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
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
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
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
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