Business · 17/11/2025Updated: 10/17/2026 · 1 min read
FDA Issues Final Guidance on Expanded Access to Investigational Drugs for Treatment Use
Summary
The FDA has released a final guidance on expanded access to investigational drugs for treatment use, replacing previous guidance issued in 2016 and 2022, and addressing frequently asked questions related to FDA regulations and the 21st Century Cures Act.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →