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

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Docket Number: FDA-2013-D-0446 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides information for industry, researchers, physicians, institutional review boards, and patients about the implementation of FDA’s regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (21 CFR part 312, subpart I), which went into effect on October 13, 2009. FDA received numerous questions concerning implementation of the regulatory requirements for expanded access. As a result, FDA issued the guidance for industry Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers (June 2016, updated October 2017), providing recommendations in a question-and-answer format, addressing the most frequently asked questions. Since 2017, FDA has received additional questions concerning implementation of the regulatory and statutory requirements of expanded access to investigational drugs, including those added by the 21st Century Cures Act and the FDA Reauthorization Act of 2017.

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• ## Content current as of:

04/17/2026

• Regulated Product(s)

  • Drugs

Topic(s)

• Administrative / Procedural