FDA Policy/General
After a year at the agency, FDA deputy commissioner for operations and chief operating officer Barclay Butler has announced his retirement in the coming months, according to an internal email. FDA commissioner Marty Makary has named Butler’s deputy, Melanie Keller, to assume his duties effective 4/6. Before joining
FDA Policy/General
FDA has placed a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.’s experimental therapy for myotonic dystrophy Type 1. The action affects the Phase 2 FREEDOM2-DM1 multiple ascending dose study of PGN-EDODM1 in patients with myotonic dystrophy Type 1. According to PepGen,
FDA Policy/General
FDA has finalized a sweeping overhaul of the National Drug Code system, adopting a standardized 12-digit format for the identifier used to uniquely distinguish prescription and over-the-counter drugs marketed in the U.S. Under a new final rule, the agency will replace the current 10-digit National
FDA Policy/General
Three former senior FDA officials have told a federal appeals court that the Trump administration mischaracterized the science on contraceptive safety when it expanded religious and moral exemptions to the Affordable Care Act’s birth control coverage mandate. In an amicus brief filed with the U.S. Court of Appeals
FDA Policy/General
HHS has directed FDA and other health agency employees to immediately stop using the artificial intelligence (AI) platform Claude, disabling access across its enterprise systems after the Trump administration labeled parent company Anthropic a “supply chain risk,” according to a post on NOTUS.org. In an email sent Monday by
FDA Policy/General
FDA commissioner Marty Makary is defending the agency’s scientific standards and personnel, particularly CBER director Vinay Prasad, amid mounting political and investor criticism. In a 2/26 CNBC interview about recent FDA review policy changes (e.g., not requiring two pivotal trials for approval, and this week’s release
FDA Policy/General
FDA says its ability to uphold the “gold standard” of regulatory review depends as much on protecting confidential information as it does on scientific rigor. In a recent FDA Voices post, FDA chief operating officer Barclay Butler says the agency operates at a “unique crossroads” between transparency and confidentiality. While
FDA Policy/General
A new analysis published in JAMA Health Forum examines FDA’s quiet but significant shift in how it seeks outside scientific advice, raising legal and credibility concerns about the agency’s decision-making process. In the article, C. Joseph Ross Daval and Aaron S. Kesselheim contend that FDA has scaled
FDA Policy/General
The Center for Veterinary Medicine (CVM) says promotional communications for Elanco Animal Health’s Pradalex (pradofloxacin injection) contain false or misleading claims and representations about the product’s safety and effectiveness. A just-released 1/6 Warning Letter says the promotional communications misbrand Pradalex, which CVM says is especially concerning
FDA Policy/General
FDA has published a guidance, Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals, to facilitate voluntary changes to have all medically important antimicrobial new animal drugs administered in alignment with the principles of judicious use. The document says the affected drugs are: (1)
FDA Policy/General
Public confidence in FDA and Centers for Disease Control and Prevention remains low following recent changes to the federally recommended childhood vaccine schedule, according to a new Kaiser Family Foundation (KFF) poll. The survey, conducted weeks after the Trump administration announced significant revisions to childhood vaccine recommendations, found that fewer
FDA Policy/General
Sangamo Therapeutics has begun a rolling BLA submission seeking accelerated approval of its experimental Fabry disease gene therapy, following results from a registrational study that the agency has agreed can serve as the primary basis for approval. The company says that data from its Phase 1/2 STAAR study support
FDA Policy/General
FDA’s regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, even as the agency now faces workforce reductions and organizational restructuring that could further strain its oversight capacity, according to a new report from the Government Accountability Office. The just-released GAO report examines how FDA’s authority,
FDA Policy/General
FDA has released a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The document applies to devices with cybersecurity considerations, including but not limited to those that have a device software function or that contain software (including firmware) or programmable logic, and it
FDA Policy/General
FDA deputy chief of staff Samuel Doran is the target of an HHS Office of Inspector General (OIG) ethics investigation on whether he misled the federal government by using a sham divorce to conceal potential conflicts of interest, according to a Bloomberg report. At issue is the relationship between Doran
FDA Policy/General
The current climate at FDA is unprecedented in terms of the depth and breadth of its politicization. That’s the view of University of Southern California economist and associate professor of public policy Genevieve Kanter in an online interview with PharmaVoice. She says that while all presidential administrations use appointed
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a TV ad for ARS Pharmaceutical’s Neffy (epinephrine nasal spray) is false and misleading. A 1/23 Untitled Letter says the agency is concerned that it raised similar issues in a 9/9/2025 Untitled Letter and asked the company
FDA Policy/General
The year 2025 marked a period of significant transformation in FDA and Department of Justice (DoJ) enforcement activities. While traditional priorities around product quality, safety, and clinical research integrity remained central, the enforcement landscape increasingly reflected the current administration’s policy objectives, workforce restructuring, and evolving legal frameworks. A Ropes
FDA Policy/General
U.S., U.K. and Canadian drug regulators are announcing a 6/2-4 joint international symposium to discuss evolving regulatory expectations for clinical trials, bioequivalence studies and pharmacovigilance, according to a meeting notice posted by FDA. The three-day FDA/MHRA/Health Canada Symposium is expected to draw regulators,
Drugs
Six King & Spalding attorneys say the over 200 drug advertising and promotion enforcement letters FDA issued in 2025 hit a nearly-25-year high. Writing in an online blog post, the attorneys say the vast majority of the letters were issued after the agency’s 9/9/2025 announcement
FDA Policy/General
Former FDA Oncology Center for Excellence director Richard Pazdur is warning that political interference and internal upheaval are eroding the agency’s ability to function as a science-driven organization, according to public remarks delivered at a biotech industry gathering in San Francisco. He said the traditional firewall between scientific
FDA Policy/General
FDA’s latest enforcement action against a schizophrenia drug advertisement offers a pointed reminder of how narrowly the agency continues to interpret permissible direct-to-consumer claims, according to regulatory attorneys reviewing the case. A 12/15 Notice of Violation letter describes the TV ad produced by Bristol Myers Squibb’