Building a National Framework for the Establishment of Regulatory Science for Drug Development. Workshop Summary

摘要

The U.S. Food and Drug Administration (FDA) today has a broad range of responsibilities, regulating fully 25 percent of the American economy, including 80 percent of the nation's food supply and all drugs, devices, dietary supplements, animal drugs, cosmetics, biologics, and tobacco products. These responsibilities go far beyond those mandated in the agency's originating legislation--the 1906 Pure Food and Drugs Act and the 1938 Federal Food, Drug, and Cosmetics Act. The agency was initially established to prevent the entry of adulterated products into the public market; it was from its inception grounded in principles of scientific study in support of its core mission of regulating consumable goods. That mission remains today; however, the agency has assumed a far more scientifically complex and international reach, with centers located around the world. In the face of rapid advances in medicine and biomedical science, the FDA faces pressure to keep pace with new technologies and develop the expertise necessary to regulate those technologies as they emerge.