Research Roundup: FDA Uses Fall and Winter 2021 to Release Significant New Guidance Governing Hot-Button Life Sciences Research Topics
Arnold Porter
DECEMBER 20, 2021
FDA’s decision to issue this investigator-specific guidance follows publication of a draft sponsor-specific safety reporting guidance in June 2021, and is part of an effort to ultimately replace the older guidance documents with role-specific guidance. 2021) (RWE Draft Guidance). A summary of these documents follows below.
Let's personalize your content