Division of Clinical Research

Office of the Vice President and Innovation

(6/2/2020) – FDA is issuing this “Guidance for IRBs and Clinical Investigators” to provide recommendations regarding the key factors and procedures IRBs should consider when reviewing expanded access submissions for individual patient access to investigational drugs for treating COVID-19.

See document here: https://www.fda.gov/media/138496/download

Categories COVID-19
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