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Congress has enacted law codified at Title 21, United States Code, section 1, et seq., and the rules promulgated thereunder in the Code of Federal Regulations. Particularly, the Federal Food, Drug and Cosmetic Act, Title 21, United States Code, section 301, et seq.
Congress thus created the United States Food and Drug Agency, an agency of the United States Department of Health and Human Services. One of the most prominent agencies of the USHHS, the FDA exercises authority and jurisdiction over this subject matter. The FDA extensively regulates clinical research, clinical trials, production, and the ongoing scrutiny of the safety of pharmaceuticals manufactured in, marketed in, and imported into, the United States.
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