FDA Issues Guidance on Expanded Access to Investigational Drugs
November 23, 2025
November 23, 2025
WASHINGTON, Nov. 23 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration announced the availability of a final guidance for industry entitled "Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers."
The guidance addresses common inquiries related to expanded access, which permits the use of an investigational drug when the primary goal is to diagnose, monitor, or treat a patient's condition rather than to . . .
The guidance addresses common inquiries related to expanded access, which permits the use of an investigational drug when the primary goal is to diagnose, monitor, or treat a patient's condition rather than to . . .