Knowra Food and Drug Administration Food and Drug Administration The Food and Drug Administration is a United States federal agency that regulates the safety, effectiveness, and security of foods, drugs, biologics, medical devices, and related products.
New Drug Application : A submission asking the FDA to approve a new drug for marketing in the United States. This is the principal route for approving many new prescription drugs.
Federal Food, Drug, and Cosmetic Act : A United States federal law that gives the FDA authority over foods, drugs, cosmetics, and medical devices. It supplies much of the agency's basic regulatory authority.
United States Pharmacopeia : A compendium of standards for the identity, strength, quality, and purity of medicines. Its standards helped establish a foundation for federal drug oversight.
Drug repurposing : The use of an existing drug to treat a condition different from its original approved indication. FDA labeling and approval pathways shape how repurposed treatments reach patients.
Federal Trade Commission : A United States federal agency that enforces laws against unfair competition and deceptive commercial practices. It shares some advertising oversight with the FDA, especially for foods and supplements.
Premarket Approval : The FDA process for evaluating the safety and effectiveness of certain high-risk medical devices before marketing. It sets a demanding premarket review pathway for many high-risk devices.
Biologics Control Act : A 1902 United States law establishing federal oversight of the safety and purity of vaccines and other biological products. It established an early legal foundation for regulating biologics.
Pure Food and Drug Act : A 1906 United States law that prohibited interstate commerce in adulterated or misbranded foods and drugs. It marked a major beginning of federal food and drug regulation.
Orphan Drug Act : A 1983 United States law offering incentives to develop treatments for rare diseases. It uses regulatory and economic incentives to address gaps in rare-disease treatment.
United States Department of Agriculture : A United States federal department responsible for agriculture, food programs, and specified food-safety functions. Its food-safety responsibilities overlap with, but differ from, the FDA's.
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