Lin, Henry, M.D. – FDA Warning Letter, Jul 1, 2009

This FDA Warning Letter, Ref: 10-HFD-45-03-01, dated September 15, 2008, and July 1, 2009, addresses Henry Lin, M.D., regarding his conduct as sponsor-investigator and then sponsor of clinical investigation Protocol (b)(4) for investigational drug (b)(4). Inspections on September 15, 2008, and July 1, 2009, revealed non-adherence to statutory requirements and FDA regulations.

Key violations as sponsor include: 1. **Failure to ensure proper monitoring of clinical investigations** [21 CFR 312.50 and 312.56(a)]: Dr. Lin did not monitor any aspect of the study, relying insufficiently on a Data Safety Monitoring Board (DSMB) that only monitored adverse events. 2. **Failure to obtain a signed investigator statement (Form FDA 1572)** [21 CFR 312.53(c)(1)]: Dr. Lin allowed Dr. (b)(4) to participate as clinical investigator without obtaining a signed Form FDA 1572 from her, and the one provided was signed by Dr. Lin over two years after enrollment began. 3. **Failure to give each participating investigator an investigator brochure** [21 CFR 312