Louisiana State University Health Science Center IRB

Warning LetterOpen

Charles C. Coleman, M.D. IRB Chair Louisiana State University Health Science Center IRB 433 Bolivar Street, Suite 206 New Orleans , LA 70112 United StatesFEI 2310620Issued Sep 27, 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 2310620.

Violations4

Issue DateSep 27, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Louisiana State University Health Science Center IRB
Location: Charles C. Coleman, M.D. IRB Chair Louisiana State University Health Science Center IRB 433 Bolivar Street, Suite 206 New Orleans , LA 70112 United States
FEI Number: 2310620
Country: United States
Issue Date: September 27, 2024
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Louisiana State University Health Science Center's IRB failed to conduct continuing review of drug research studies at the required intervals of not less than once per year, in violation of 21 CFR 56.109(f). The inspection conducted between July 17-26, 2023, identified that the IRB did not adhere to applicable statutory requirements of the FD&C Act and FDA regulations governing the protection of human subjects in clinical investigations. This violation was part of the FDA's Bioresearch Monitoring Program designed to ensure the rights, safety, and welfare of human research subjects were adequately protected.

Louisiana State University Health Science Center IRB FDA Warning Letter, September 27, 2024