FDA WARNING_LETTER - Cohen, Yale M.D. - February 11, 2011

On February 7-11, 2011, the FDA inspected Dr. Yale Cohen's clinical investigation of investigational drug (b)(4) (Protocol (b)(4)). This Warning Letter, dated August 12, 2011, cites recurring violations of FDA regulations and statutory requirements, some previously noted in an October 8, 2009, letter.

Key violations include: 1. **Failure to conduct the investigation according to the investigational plan [21 CFR 312.60]:** Dr. Cohen failed to record and report adverse events (AEs) and serious adverse events (SAEs) in CRFs and to the sponsor, including instances of shortness of breath, bronchitis, viral infection, neck pain/fall, back pain, fall/head injury, claudication, and edema. The FDA deemed his corrective actions inadequate, noting prior similar findings in August 2008 and a failure to implement previously promised SOPs and staff training. 2. **Failure to maintain adequate and accurate case histories [21 CFR 312.62(b)]:** * Dosing decisions for subjects were only documented on unsigned "face sheets" by the study coordinator, with no confirmation of Dr. Cohen's verbal orders. This was a recurrence of a violation cited in October 2009, where Dr. Cohen had promised to personally review