| Subject: | FDA Issues Draft Guidance on Institutional Review Board Continuing Review After Clinical Investigation Approval |
| Category: | Food and Drug Administration (FDA)
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| Published: | Wed, 13 Jan 2010 - 12:00 pm |
| The Food and Drug Administration (FDA) has issued draft guidance on Institutional Review Board (IRB) Continuing Review after Clinical Investigation Approval. The guidance is intended to assist IRBs in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations. The draft... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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