CHAIR
:
Roy Baranello, Jr., Assistant Vice President, Regulatory Policy and operations, Wyeth
SPEAKER
(S):
Steven K. Galson, M.D., MPH, Director, Center for Drug Evaluation and Research, Food and Drug Administration
Jesse L. Goodman, MD, MPH, Director, Center for Biologics Evaluation and Research
Description
In this session, senior FDA leaders will discuss current "hot topics" in each of the centers for review of drugs and biologics, CDER and CBER, including the latest on key FDA organizational and policy initiatives, drug safety and the third reauthorization of the Prescription Drug User Fee Act. Time is planned for interactive discussion with attendees on any of the topics presented.
Objectives:
Outline key FDA organizational and policy initiatives.
Present FDA's views on critical topics such as drug safety and "Critical Path."
Stimulate interactive discussion between FDA and attendees with respect to the initiatives and issues presented by FDA.