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Guidance on Continuing Review for IRBs

01/13/2010

Federal Register Notice: FDA is making available a draft guidance, Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval. It provides recommendations to institutional review boards (IRBs) on the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations. The draft guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review. To download this guidance, click here. To view this notice, click here.

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