FDA Policy/General
FDA sharply increased enforcement activity against drugmakers and distributors in fiscal year 2025, issuing 303 Warning Letters to companies involved with drugs and biologics — up 59% from 190 letters in FY2024 — according to a new analysis from consulting firm Eliquent Life Sciences. The report, authored by regulatory experts Erin Hartmann
FDA Policy/General
Several emerging regulatory and enforcement developments at FDA are expected to have significant implications for pharmaceutical, medical device, and digital health companies in 2026, according to a new legal update from ArentFox Schiff. The report highlights intensifying FDA enforcement activity, evolving regulatory frameworks, and growing litigation risks tied to agency
FDA Policy/General
FDA commissioner Marty Makary says the artificial intelligence (AI) tools the agency has implemented have saved its 14,000 staffers some 17,000 hours of human work time in the measurement period the agency has assessed since implementation at the end of 6/2025. In an online interview with Healthcare
FDA Policy/General
FDA has launched its new FDA Adverse Event Monitoring System (AEMS), a searchable new platform for analyzing adverse event reports. An agency statement says AEMS “represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.” According to FDA commissioner
FDA Policy/General
Newsweek says FDA “has faced an unusual convergence of political, scientific, legal and operational pressure in recent months, as it balances public health demands with intensifying scrutiny from the White House, Congress, industry and patient advocates.” The magazine details four major issues that it says have plagued the agency in
FDA Policy/General
The Institute for Safe Medicines says FDA, the Federal Trade Commission, and the Department of Justice should take immediate action against Hims & Hers for its Super Bowl ad that promoted unapproved compounded drug products. A 3/3 letter to FDA says the ad “contained a startling array of unsubstantiated
FDA Policy/General
Five Sidley attorneys say the FDA 9/2025 crackdown on direct-to-consumer (DTC) prescription drug ads has involved Warning and Untitled Letters that were issued to drug manufacturers that articulate positions that “raise significant constitutional, legal, and regulatory concerns.” Their legal update notes that a recent Untitled Letter directly
FDA Policy/General
Americans express significantly greater confidence in career scientists at federal health agencies than in the leaders who oversee them, according to a new national survey that also shows declining trust in the FDA and other federal health regulators over the past two years. The survey, released 3/5 by the
FDA Policy/General
FDA has issued a draft guidance outlining how drug manufacturers should respond to inspection findings documented in an FDA Form 483, urging companies to submit detailed remediation plans quickly and take a more systematic approach to correcting quality problems. The document describes best practices for responding to inspectional observations identified
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,