FDA WARNING_LETTER - James R. Corbett, M.D. - July 08, 2019

This Warning Letter, Ref.: 20-HFD-45-02-01, dated March 10, 2020, addresses objectionable conditions observed during an FDA inspection of Dr. Corbett's clinical site from June 26 to July 8, 2019. The inspection, part of FDA’s Bioresearch Monitoring Program, reviewed the conduct of clinical investigation Protocol (b)(4) of investigational drug (b)(4), where Dr. Corbett acted as a sponsor-investigator.

The FDA concluded that Dr. Corbett failed to adhere to statutory requirements and FDA regulations. Key violations include: 1. **Failure to maintain an effective IND (21 CFR 312.50):** IND (b)(4) was terminated on June 1, 2014, due to a lack of annual reports. Despite termination, Dr. Corbett continued to enroll and administer study drug to 18 subjects until at least January 9, 2018, compromising subject safety and rights for over three years. Dr. Corbett's response, citing a misunderstanding of IND necessity for an FDA-approved drug used as a "stressor" and sponsor-investigator responsibilities, was deemed inadequate as it did not explain future clinical investigation conduct. 2. **Failure to promptly report changes to the IRB (21 CFR 312.66):