Modernizing the FDA: an incremental revolution.

Abstract

The U.S. Food and Drug Administration (FDA) is responsible for protecting consumers from unsafe or ineffective drugs and medical devices. The agency's role is defined by a growing and increasingly complex set of statutes, which reflect Congress's desires, on the one hand, to prevent product hazards and, on the other, to expedite FDA review and approval of promising new medical technologies. Congress's latest attempt to calibrate regulation to achieve these goals, the 1997 Food and Drug Administration Modernization Act, endorses certain of the FDA's own innovations and changes in the agency's ways of doing business.