Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistLarkin Community Hospital's Institutional Review Board (IRB) failed to comply with FDA regulations protecting human subjects in drug research studies. During a November 2021 inspection, the FDA found that the IRB did not conduct required convened meetings with a majority of members present before approving proposed research, violating 21 CFR 56.108(c) and related provisions governing clinical drug investigations. The IRB's December 2021 response to the inspection observations was deemed insufficient to address the regulatory violations identified.