FDA 483 - Applied Therapeutics, Inc. - May 03, 2024

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.