About me
James Bertram is currently the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration (FDA). OCP is responsible for the assignment of combination products to FDA’s medical product centers for review, helps coordinate timely, effective, and aligned reviews of combination products and oversees the postmarket activities of combination products. Prior to joining OCP, James was the Associate Director with the Regulatory Policy and Combination Products Staff which supported the Office of Product Evaluation and Quality in CDRH.
