The Mesothelioma SOS Glossary - Food and Drug Administration (FDA)

The Food and Drug Administration, or FDA is a government agency responsible for making sure that all drugs, vaccines, cosmetics, medical devices, dietary supplements, foods and blood products are safe within the United States. The FDA is part of the Department of Health and Human Services in the United States, which makes up one of the Cabinet Departments in the United States Government. The Food and Drug Administration has five main groupings: The Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM). Each of these five centers regulates and researches in their respective fields. Today, the Center for Drug Evaluation and Research, which regulates pharmaceuticals and approves new treatments, has many “review teams” which work daily to determine the safety and effectiveness of new drugs and methods of treatment. Typically, before the FDA will approve a new treatment or pharmaceutical, a four-phased clinical trial must be conducted, which typically includes about 1,000 to 3,000 patients.