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US FDA clarifies rules on expanded access to investigational drugs

This article was originally published in SRA

Executive Summary

All applications for patients to receive an investigational drug under the US Food and Drug Administration's expanded access regulation must undergo a full review by an institutional review board, the agency has clarified in a draft guideline1,2. In a separate document, the FDA also explains the circumstances in which it may be appropriate for sponsors to charge patients for being allowed access to investigational drugs3,4.

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