2022-23785: Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers." Since 2017, FDA has received many questions concerning implementation of the regulatory requirements of the expanded access program. In addition, FDA developed recommendations for fulfilling the new requirements for expanded access submissions promulgated in the 21st Century Cures Act (Cures Act) (2016) and the FDA Reauthorization Act of 2017 (FDARA). FDA is providing this guidance in a question-and- answer format, addressing the most recent frequently asked questions and sharing recommendations to fulfill the new statutory requirements. This guidance revises the guidance of the same title issued in June 2016 and updated in October 2017.
The agency’s own summary, as published.
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