Food and Drug Administration Modernization Act of 1997

Food and Drug Administration Modernization Act of 1997
Great Seal of the United States
Long titleA bill to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes.
Acronyms (colloquial)FDAMA
Enacted bythe 105th United States Congress
EffectiveNovember 21, 1997
Citations
Public law105-115
Statutes at Large111 U.S. Stat 2296
Codification
Acts amendedFederal Food, Drug and Cosmetic Act
Titles amendedTitle 21 USC 301: Food and Drugs
Legislative history
  • Introduced in the Senate as S.830 by
    • Sen Spencer Abraham
    • Sen Daniel Coats
    • Sen Christopher J. Dodd
    • Sen William H. Frist
    • Sen Chuck Hagel
    • Sen James M. Jeffords
    • Sen Connie Mack, III
    • Sen Barbara A. Mikulski
    on June 5, 1997
  • Committee consideration by
    • Senate Labor and Human Resources
    • House Commerce
    • Subcommittee on Health and Environment
  • Signed into law by President William J. Clinton on November 21, 1997

The United States Food and Drug Administration Modernization Acts (FDAMA) are amendments to the Federal Food, Drug, and Cosmetic Act, which regulated products by the FDA. The first bill, the FDA Modernization Act of 1997, reduced the timeline for approving new pharmaceutical drugs. It also loosened rules around broadcast pharmaceutical advertising.

In 2022, the Act was updated with the FDA Modernization Act 2.0, which cancelled a 1938 mandate to require animal testing for every drug development protocol.