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

On November 27, 2024, the FDA issued a Warning Letter to Applied Therapeutics, Inc. following an inspection from April 29 to May 3, 2024, concerning their role as sponsor of clinical investigation Protocol (b)(4). The inspection, part of the Bioresearch Monitoring Program, identified significant violations of the Federal Food, Drug and Cosmetic Act and 21 CFR 312.

The first violation cited was the failure to permit FDA access to and copy and verify records [21 CFR 312.58]. Specifically, a third-party vendor deleted electronic data, including audit trails, for critical eCOAs from Pearson’s Q-global® for all 47 subjects in Protocol (b)(4) on March 27, 2024, preventing FDA verification. While Applied Therapeutics implemented corrective actions like data backups and restricting vendor deletion capabilities, the FDA deemed the response inadequate due to insufficient detail and continued inability to verify the deleted electronic data.

The second violation was the failure to provide FDA with relevant safety and effectiveness data [21 CFR 314.50(d)(5)(iv)]. Applied Therapeutics failed to report dosing errors for the investigational drug (b)(4), where a mislabeled formulation led to subjects receiving 80% of the required dose between March and June 2021. This information, relevant to drug safety and effectiveness