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Answers for Industry: Updated FDA Guidance re: IRB, Adverse Events, Cures Act

This Q&A document from FDA outlines October 2017 updates to Guidance on Expanded Access to Investigational Drugs for Treatment Use. It covers waivers for convened IRB meetings, addresses how the FDA reviews adverse event data related to expanded access and explains the 21st Century Cures Act requirement that EA policies be publicly posted. 

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