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Program Code:
3900
Date:
Wednesday, May 20, 2009
Time:
8:00 AM to 9:30 AM
EST
SPEAKER
(S):
Jonca Bull, Novartis Pharmaceuticals, Inc
Douglas Throckmorton, MD, Deputy Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Robert Yetter, PhD, Acting Special Assistant to the Associate Director , U.S. Food & Drug Administration
Description
In this session, senior U.S. Food and Drug Administration leaders will discuss current hot topics in each of the centers for review of drugs and biologics, CDER and CBER, including implementation of the FDA Amendments Act of 2007 & PDUFA IV, drug safety initiatives, Critical Path programs and other key FDA organizational and policy initiatives. Time is planned for interactive discussion with attendees.
• Outline key FDA organizational and policy initiatives
• Present FDA's views on critical topics such as the FDA Amendments Act, drug safety and Critical Path programs
• Stimulate interactive discussion with respect to the initiatives and issues presented