David Burrow, PharmD, JD
Director, Office of Scientific Investigations
U.S. Food and Drug Administration
As the director of the Office of Scientific Investigations, I lead the regulation, policy, and enforcement of clinical research. Including the development of all BIMO-related policy documents, internal operations, and inspection processes. I also lead the inspection, classification, and issuance of all enforcement actions for all CDER-regulated BIMO cases. Lastly, I led the assessment of data reliability for all clinical research submitted to the FDA in support of marketing applications - both studies conducted under INDs, and not conducted under INDs (from outside the US).