Sabine S. Hazan, M.D.

Warning LetterOpen

Sabine S. Hazan, M.D. President, Topelia Therapeutics Sabine S. Hazan, M.D. 1835 Knoll Drive Ventura , CA 93003-7321 United States (b)(6)FEI 3016661283Issued Feb 28, 2022Center 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 3016661283.

Violations1

Issue DateFeb 28, 2022

Product TypeOther

StatusOpen

Letter Details

Firm: Sabine S. Hazan, M.D.
Location: Sabine S. Hazan, M.D. President, Topelia Therapeutics Sabine S. Hazan, M.D. 1835 Knoll Drive Ventura , CA 93003-7321 United States (b)(6)
FEI Number: 3016661283
Country: United States
Issue Date: February 28, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Other
Status: Open

Summary

Dr. Sabine S. Hazan, operating as President of Topelia Therapeutics, failed to comply with federal regulations governing the conduct of clinical drug investigations during FDA's inspection of her clinical site in September 2021. The primary violation involved her failure to ensure that an Institutional Review Board (IRB) compliant with 21 CFR part 56 conducted initial and continuing review and approval of proposed clinical studies, as required under 21 CFR 312.66. This deficiency in IRB oversight represented a fundamental breach of protections designed to safeguard the rights, safety, and welfare of human research subjects participating in multiple clinical protocols under her direction.

Sabine S. Hazan, M.D. FDA Warning Letter, February 28, 2022