Introduction: Managing the Risks From Medical Product Use
As set forth by Congress in section 406 of the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the mission of the U.S. Food and Drug Administration (FDA) is, in part, to (1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate and timely action on the marketing of regulated products and (2) protect the public health by ensuring that human drugs, including biologics, are safe and effective and that there is reasonable assurance of the safety and effectiveness of medical devices intended for human use. FDA is charged with pursuing this mission through consultation with experts in science, medicine, and public health, and through cooperation with consumers, users, and industry. The Modernization Act also instructs FDA to maximize the availability and clarity of information concerning new products for consumers and patients.
During the 1980s and the early 1990s, critics talked of a drug lag in the United States. They claimed that long review times were denying the American public the benefits of new products that were available in other developed nations many months or years earlier.