Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

1 November 2022 – FDA published draft Q&A guidance on expanded access to investigational drugs for treatment use. Submit comments by 3 January 2023.

FDA issued guidance providing recommendations in a question-and-answer format, addressing the most frequently asked questions. The updates include additional recommendations related to IRB review, informed consent, and new requirements established by the Cures Act and FDARA related to sponsors making their policies for evaluating and responding to expanded access requests (i.e., expanded access policy) public and readily available.