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U.S. Department of Health and Human Services

Regulatory Information

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FDAAA Information for Drugs


The Federal Food, Drug, and Cosmetic Act gives FDA authority to regulate drugs, food, medical devices, and other products. Congress adds new provisions from time to time - or expands and enhances existing ones - to enable the agency to do its job more efficiently.

On Sept. 27, 2007, the President signed into law the Food and Drug Administration Amendments Act (FDAAA) of 2007. FDAAA reauthorizes some existing parts of the law (e.g., User Fees) and adds many new provisions to the Federal Food, Drug, and Cosmetic Act. During the coming months, CDER will be implementing the provisions of this landmark legislation. As we implement the new statute, we will make relevant documents available here.