Rogerio Lobo, M.D. – FDA Warning Letter, Jun 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