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Dr. Namita A. Goyal, a clinical investigator conducting a biologics study, failed to ensure the investigation was conducted according to the signed investigator statement and protocol requirements. The FDA inspection (June 2023) found that subjects were enrolled despite failing to meet required eligibility criteria, including one subject who participated while meeting an exclusion criterion for concurrent participation in another clinical trial within 30 days of screening. These violations of 21 CFR §312.60 and §312.50 demonstrated inadequate protections for human subjects' rights, safety, and welfare in the investigational product study.