U.S. Food and Drug Administration

FDA Modernization Act of 1997

The Act

The Food and Drug Administration Modernization Act (FDAMA), enacted Nov. 21, 1997, amended the Federal Food, Drug, and Cosmetic Act relating to the regulation of food, drugs, devices, and biological products. With the passage of FDAMA, Congress enhanced FDA's mission in ways that recognized the Agency would be operating in a 21st century characterized by increasing technological, trade and public health complexities.

FDA Plan for Statutory Compliance (November 1998)

FDAMA Implementation Chart

FDAMA Archives


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