Diaz, Leslie, M.D. – FDA Warning Letter, Mar 8, 2011

The FDA issued a Warning Letter to Dr. Leslie E. Diaz following an inspection from January 12 to March 8, 2011, concerning two clinical investigations: Protocol (b)(4) for investigational drug (b)(4) and Protocol (b)(4) for investigational drug (b)(4). The inspection, part of the Bioresearch Monitoring Program, revealed significant violations of FDA regulations governing clinical investigations.

Key violations include: 1. **Failure to Personally Conduct or Adequately Supervise:** Dr. Diaz failed to ensure the studies were conducted according to the investigational plan and regulations, acknowledging a "lack of involvement and oversight." This included not opening critical correspondence from monitors, sponsors, and IRBs regarding study terminations and failing to evaluate/grade adverse experiences (AEs) as required. 2. **Failure to Conduct Investigation According to Plan:** * **Protocol (b)(4):** Enrolled a subject with severe renal insufficiency despite exclusion criteria. Failed to evaluate/grade AEs for multiple subjects. Failed to report a serious adverse experience (SAE) within the required 24-hour window and did not provide all requested information on the SAE form. * **Protocol (b)(4):** Dispensed investigational medication to a subject nearly two weeks before confirming eligibility. 3. **Failure to Return Unused Drug Supplies:** Unreturned investigational drugs for both studies were