FDA WARNING_LETTER - Scott, David F., M.D. - March 24, 2010

On October 20, 2010, the FDA issued a Warning Letter to Dr. David F. Scott following an inspection conducted between March 15 and March 24, 2010. The inspection, part of FDA's Bioresearch Monitoring Program, reviewed Dr. Scott's conduct of two clinical investigations: Protocol (b)(4) for investigational drug (b)(4) and Protocol (b)(4) for investigational drug (b)(4).

The FDA concluded that Dr. Scott failed to adhere to statutory requirements and FDA regulations governing clinical investigations and human subject protection. Key violations included:

1. **Failure to conduct investigations according to signed investigator statements and investigational plans [21 CFR 312.60]:** * **Protocol (b)(4):** Ten subjects were randomized before surgery, contrary to the protocol and prior to sponsor approval of an exemption request. Physical examinations at Day 10/early termination were not performed for any randomized subjects. Pharmacokinetic testing was not performed on 11 of 13 required subjects. Subject 4033017 was enrolled despite taking aspirin > 162 mg/day, violating an exclusion criterion. Venography was not performed for 7 of 16 randomized subjects. Subject 4033021 was screened after the sponsor instructed to suspend screening. * **Protocol (