FDA WARNING_LETTER - Michlin, Bernard A., MD - January 23, 2015

On July 13, 2015, the FDA issued a Warning Letter to Bernard A. Michlin, M.D., following an inspection from January 8 to January 23, 2015, as part of the Bioresearch Monitoring Program. The inspection reviewed Dr. Michlin's conduct of clinical investigations for investigational drugs (b)(4) and (b)(4), sponsored by (b)(4) and (b)(4) respectively.

The FDA concluded that Dr. Michlin failed to adhere to statutory requirements and FDA regulations, specifically 21 CFR 312.60, by not ensuring the investigations were conducted according to the investigational plan. Key violations included:

1. **Failure to perform required safety laboratory tests:** For Protocol (b)(4), screening blood samples (virology, hematology, clinical chemistry) were not collected for eight subjects (614005, 614009, 614015, 614016, 614017, 614019, 614022, 614023). 2. **Failure to perform required urine drug screens:** For Protocol (b)(4), urine drug screens were not performed at screening or on specified days for multiple subjects (e.g., Subject 6140