FDA WARNING_LETTER - Rogerio Lobo, M.D. - June 25, 2013

This Warning Letter details objectionable conditions observed during an FDA inspection of Dr. Rogerio A. Lobo's research office at Columbia University Medical Center (CUMC) from June 5-25, 2013, regarding his role as sponsor of clinical investigation Protocol (b)(4) of investigational drug (b)(4). The inspection, part of FDA's Bioresearch Monitoring Program, found non-adherence to statutory requirements and FDA regulations for clinical investigations and human subject protection.

Key violations include: 1. **Failure to ensure proper monitoring and protocol adherence (21 CFR 312.50 and 312.56(a))**: Dr. Lobo failed to identify and correct a clinical investigator's failures in a timely manner. * **Inadequate Informed Consent (21 CFR 321.60 and 50.20)**: Monitoring did not identify that 26 of 50 subjects lacked informed consent, and 12 subjects received investigational drug before obtaining consent. * **Lapsed IRB Approval (21 CFR part 56)**: Monitoring failed to identify that IRB approval for Protocol (b)(4) lapsed from March 31 to June 3, 2011, during which 6 subjects were enrolled and treated. * **Failure to Administer Correct Drug Doses**: Monitoring did not identify