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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.