FDA Pilots Faster Clarifications to Meeting Minutes

Silver Spring, Md., Nov. 19, 2025 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings. Through the program, sponsors are given a “Meeting Minute Clarification Opportunity” which gives them the opportunity to obtain a quick clarification of a response from a single discipline.

“In this industry, time is a precious commodity. Numerous drug developers have told me that a quick touchpoint or clarification opportunity with the FDA team could spare them months of guesswork,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Our goal is to give sponsors prompt, clear feedback so they can focus on what they do best: delivering more cures and innovative treatments to the American people.” 

Specifically, sponsors will be able to submit a question via email and agency staff will aim to respond within three business days by email. Since the pilot launched in October, the agency has provided several helpful clarifications to sponsors following receipt of FDA meeting minutes. 

The program is being piloted by the FDA’s Office of New Drugs and is part of the agency’s broader initiative to streamline the drug development process and improve agency interactions with sponsors. The agency intends to expand these practices across FDA centers.  

Contact Info

U.S. Food and Drug Administration
[email protected]
+1 202-690-6343

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