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 Today, the U.S. Food and Drug Administration issued a revised draft guidance for industry, “Expanded Access to Investigational Drugs for Treatment Use Questions and Answers.” This revised draft guidance responds to frequently asked questions about the FDA’s regulation of expanded access to investigational drugs and includes the agency’s recommendations for fulfilling new requirements of the 21st Century Cures Act and the FDA Reauthorization Act of 2017 that are related to expanded access.
Since FDA issued the “Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers" final guidance in June 2016 (revised in October 2017), the agency has received questions from stakeholders related to the implementation of the regulatory requirements of the expanded access program. The revised draft guidance provides further clarification to some of the recommendations included in the 2017 guidance and includes additional recommendations about FDA’s current processes and policies regarding expanded access to investigational drugs.
FDA is providing this revised guidance in a question-and-answer format, to address the most recently asked questions and sharing recommendations to fulfill new statutory requirements.
When finalized, this guidance will replace the June 2016 (updated in October 2017) final guidance, "Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers."
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