FDA 483 - Applied Therapeutics, Inc. - May 03, 2024
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An FDA inspection of Applied Therapeutics, Inc. in New York, NY, revealed significant deficiencies in the conduct of a clinical study. The firm failed to adhere to its protocol and investigational plan, leading to issues such as deleted source data, numerous discrepancies in efficacy endpoint assessments, and a lack of proper documentation for data changes. These findings highlight serious concerns regarding data integrity and quality assurance in their clinical trials.
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