Center for Drug Evaluation and Research (CDER) discusses how they execute emergency preparedness and response to public health incidents, including medical countermeasure (MCM) development programs, with highlights from both past public health emergencies and the current COVID-19 pandemic response.
Presenters:
Kelly Ngan, PharmD,
CDR, USPHS
Team Leader
Project Management and Emergency Coordination
Andrea Gormley, PharmD
LCDR, USPHS
Associate Director for Regulatory Affairs
Counter-Terrorism and Emergency Coordination Staff (CTECS)
Office of the Center Director, CDER
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
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