FDA WARNING_LETTER - Richard W. Foltin, Ph.D. - March 17, 2023

This Warning Letter details objectionable conditions observed during an FDA inspection from February 28 to March 17, 2023, of Dr. Foltin's role as sponsor for multiple clinical investigations of the investigational drug (b)(4). The inspection, part of the Bioresearch Monitoring Program, identified a failure to adhere to statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 312.

Specifically, Dr. Foltin failed to submit an Investigational New Drug Application (IND) for clinical investigations of investigational new drugs subject to 21 CFR 312.2(a), as required by 21 CFR 312.20(a), 312.20(b), and 312.40(a). Protocols #(b)(4) and #(b)(4) were initiated, and human subjects were enrolled and administered study drugs, approximately 11.5 and 10.5 months, respectively, before an IND was submitted on June 8, 2022. Four subjects in Protocol #(b)(4) and six in Protocol #(b)(4) were enrolled and received study drugs prior to IND submission.

Dr. Foltin's March 23, 2023, response acknowledged the error, stating the clinical investigator was not instructed to submit new studies to