Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistDr. Maria W. Greenwald was cited for failures in conducting clinical drug investigations in accordance with FDA regulations (21 CFR 312). During an October 2022 inspection of her clinical site, FDA's Bioresearch Monitoring Program found that she failed to ensure investigations were conducted according to investigational plans, specifically failing to verify that study subjects met eligibility criteria before enrollment in Protocols (b)(4) and (b)(4). These violations represented failures to protect the rights, safety, and welfare of human research subjects as required under the Federal Food, Drug, and Cosmetic Act.