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ISOThrive, Inc. was cited for conducting clinical investigations of an investigational drug without submitting a required Investigational New Drug (IND) application to the FDA. During a June 2023 inspection as part of FDA's Bioresearch Monitoring Program, the company failed to comply with 21 CFR 312.20 and 312.40(a), which mandate that sponsors obtain IND authorization before initiating human subject studies for drugs subject to FDA oversight. The violations represented failures to adhere to statutory requirements under the Federal Food, Drug, and Cosmetic Act and applicable regulations governing the protection of human subjects in clinical research.