FDA EIR - Robert C. Bourge, M.D. - December 17, 2008

An FDA inspection of Robert C. Bourge, M.D., took place from December 15-17, 2008, to review the site's conduct in the "TRIUMPH I Study" (Protocol # LRX-TRIUMPH-001). This was a double-blind, placebo-controlled clinical investigation focusing on severe Pulmonary Arterial Hypertension, sponsored by United Therapeutics Corp., and its data supported NDA# 22-387. Dr. Bourge assumed the role of Principal Investigator in June 2008, after the study's double-blind phase had concluded.

The inspection was conducted under regulatory framework CP7348.811. Reviewing records for twenty subjects, the FDA found the site to be in general compliance with both regulations and the study protocol. There were no unreported adverse events, data discrepancies, or significant findings noted. Consequently, no FDA Form 483 (Inspectional Observations) was issued. The site demonstrated appropriate oversight of the study and its subjects. Although two subjects were enrolled under sponsor-granted waivers for specific protocol inclusion criteria, these were appropriately documented. The site was commended for its detailed progress notes and well-organized source documents. No specific violations or corrective actions were required, though the FDA's Center for Drug Evaluation and Research (CDER) will review the report and correspond with Dr. Bourge regarding his participation.