A regulatory consulting firm's report finds that 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.
A legal update from ArentFox highlight several emerging regulatory and enforcement developments at FDA thatare expected to have significant implications for pharmaceutical, medical device, and digital health companies in 2026.
A regulatory consulting firm's report finds that 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.
A legal update from ArentFox highlight several emerging regulatory and enforcement developments at FDA thatare expected to have significant implications for pharmaceutical, medical device, and digital health companies in 2026.
CBER director Vinay Prasad’s departure at the end of next month raises questions across the biotechnology sector about how the agency’s approach to vaccines, gene therapies and rare-disease treatments could change in the months ahead.
Former FDA official Grail Sipes says questions are emerging about the long-term impact of the Commissioner’s National Priority Voucher program, warning the program could expose the agency’s approval process to legal challenges and regulatory uncertainty.
