FDA WARNING_LETTER - Daniel Fred Goodman, M.D./Goodman Eye Center - December 13, 2021

The FDA issued a Warning Letter to Dr. Goodman following an inspection from November 29 to December 13, 2021, regarding the clinical investigation of investigational drug (b)(4) under Protocol (b)(4). The inspection revealed non-adherence to the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 312.

Key violations include: 1. **Failure to Submit an IND:** Dr. Goodman initiated and conducted the clinical investigation, enrolling and treating four subjects between September 17 and October 1, 2019, before the Investigational New Drug (IND) application became effective on (b)(4). The IND was submitted after initial Institutional Review Board (IRB) approval, and the IRB approval did not fulfill the IND requirement. 2. **Failure to Obtain Informed Consent and Assent:** * Legally effective written consent was not obtained from two subjects ((b)(4) and (b)(4)) before their enrollment. * Written assent, as required by the IRB for minors aged 10-17, was not obtained from six minor subjects ((b)(6), (b)(6), (b)(6), (b)(6), (b)(6), and (b)(6)) before their enrollment.

Dr. Goodman acknowledged these errors, attributing them to administrative and training issues, and stated that verbal consent/ass