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Applied Therapeutics, Inc. received a warning letter for failing to comply with federal regulations governing the conduct of clinical drug investigations as a study sponsor. During an FDA inspection conducted April 29-May 3, 2024, investigators identified that the company failed to permit FDA authorized officers access to and the ability to copy and verify records and reports related to a clinical investigation, in violation of 21 CFR 312.58. The inspection was part of the FDA's Bioresearch Monitoring Program, which evaluates whether the rights, safety, and welfare of human research subjects have been adequately protected.