RESUMEN
TThe USA Food and Drug Administration (FDA) has an over 100-year history and is the most authority drug administration.During its past records,the most important thing for FDA is facing law enforcement challenges.However,FDA insists on improving legislation and finding the perfect mode of regulation.This paper introduced the history evolution,regulatory course,present office structure of FDA,Center for Drug Evaluation and Research (CDER),and Center for Biologics Evaluation and Research (CBER).The frustration and experience for FDA is well discussed.The legislation system is interpreted through historical events.To learn the developmental and regulatory history of USA food and drug administration is important to our drug administration for practicing the mission of protecting and promoting public health.