Posted: November 6, 2008
FDA has selected Jonathan Sackner-Bernstein, MD, chief medical officer of contract research organization Clinilabs, as CDRH’s new associate director for postmarket operations. Since Sept. 2, he has been overseeing the center’s recently created matrix structure, which comprises 13 networks each responsible for a specific product category or activity.
“Each network brings together experts from various functional areas within the center, spanning premarket review to compliance and postmarket surveillance, forming cohesive groups focusing a wide variety of expertise on identifying, analyzing, and acting on specific postmarket issues,†an agency statement said.
“Dr. Sackner-Bernstein will supervise the work of the networks by providing clear direction and priorities, fostering the development of a common vision, and clarifying roles and responsibilities. As a member of the center’s senior leadership team, he will also act as a liaison between the networks and senior center management.â€
Sackner-Bernstein previously served on CDER’s Cardiovascular and Renal Drugs Advisory Panel and CDRH’s Dispute Resolution Panel.
—James G. Dickinson