How FDA Approves Drugs and Regulates Their Safety and Effectiveness. Congressional Research Service, Library of Congress. Agata Dabrowska, Susan Thaul. May 8, 2018
The Food and Drug Administration (FDA), a regulatory agency within the Department of Health and Human Services, regulates the safety and effectiveness of drugs sold in the United States. FDA divides that responsibility into two phases. In the preapproval (premarket) phase, FDA reviews manufacturers’ applications to market drugs in the United States; a drug may not be sold unless it has FDA approval. Once a drug is on the market, FDA continues its oversight of drug safety and effectiveness. That postapproval (postmarket) phase lasts as long as the drug is on the market. Beginning with the Food and Drugs Act of 1906, Congress and the President have incrementally refined and expanded FDA’s responsibilities regarding drug approval and regulation.
[PDF format, 31 pages].