Daniel Fred Goodman, M.D./Goodman Eye Center

Warning LetterOpen

Daniel Fred Goodman, M.D. Daniel Fred Goodman, M.D./Goodman Eye Center 2211 Bush Street, 2nd Floor San Francisco , CA 94115 United StatesIssued Jul 14, 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.

Violations6

Issue DateJul 14, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Daniel Fred Goodman, M.D./Goodman Eye Center
Location: Daniel Fred Goodman, M.D. Daniel Fred Goodman, M.D./Goodman Eye Center 2211 Bush Street, 2nd Floor San Francisco , CA 94115 United States
FEI Number: N/A
Country: United States
Issue Date: July 14, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Dr. Daniel Fred Goodman at Goodman Eye Center was cited for conducting clinical drug investigations without submitting a required Investigational New Drug (IND) application, violating 21 CFR 312.20(a), 312.20(b), and 312.40(a). The FDA's Bioresearch Monitoring Program inspection (November-December 2021) found that Dr. Goodman failed to adhere to federal requirements governing the conduct of clinical investigations and protection of human subjects under the FD&C Act and Title 21 CFR Part 312. This violation involved serving as both sponsor-investigator for an investigational drug without obtaining IND authorization before initiating the clinical study.

Daniel Fred Goodman, M.D./Goodman Eye Center FDA Warning Letter, July 14, 2022