Applied Therapeutics, Inc.

Warning LetterOpen

Shoshana Shendelman, Ph.D. CEO & Founder Applied Therapeutics, Inc. 545 Fifth Avenue, Suite 1400 New York , NY 10017 United StatesFEI 3017441754Issued Dec 3, 2024Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3017441754.

Violations2

Issue DateDec 3, 2024

Product TypeOther

StatusOpen

Letter Details

Firm: Applied Therapeutics, Inc.
Location: Shoshana Shendelman, Ph.D. CEO & Founder Applied Therapeutics, Inc. 545 Fifth Avenue, Suite 1400 New York , NY 10017 United States
FEI Number: 3017441754
Country: United States
Issue Date: December 03, 2024
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Other
Status: Open

Summary

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.

Applied Therapeutics, Inc. FDA Warning Letter, December 3, 2024