Food and Drug Administration Revitalization Act

The Food and Drug Administration Revitalization Act was introduced by the 101st Congress of the United States. Senator Orrin G. Hatch was the chairperson sponsor of the federal revitalization amendment for the Food and Drug Administration.

Food and Drug Administration Revitalization Act
Long titleAn Act to amend the Federal Food, Drug, and Cosmetic Act to revitalize the Food and Drug Administration, and for other purposes.
NicknamesFood and Drug Administration Revitalization Act of 1990
Enacted bythe 101st United States Congress
EffectiveNovember 28, 1990
Citations
Public law101-635
Statutes at Large104 Stat. 4583
Codification
Acts amendedFederal Food, Drug, and Cosmetic Act
Titles amended21 U.S.C.: Food and Drugs
U.S.C. sections amended
Legislative history
  • Introduced in the Senate as S. 845 by Orrin G. Hatch (R–UT) on April 19, 1989
  • Committee consideration by Committee on Labor and Human Resources and House Committee on Energy and Commerce
  • Passed the Senate on October 25, 1990 (passed)
  • Passed the House on October 27, 1990 (agreed by voice vote)
  • Signed into law by President George H. W. Bush on November 28, 1990

The FDA revitalization was orchestrated by Commissioner of Food and Drugs Dr. David Kessler in pursuant of the congressional authorization permissible by 101st Senate bill 845;

☆ Digital transformation and Information technology harmonizing FDA as information agency
☆ Enforcement programs streamlined by contingencies of FDA field activities
☆ Establishment of Office of Criminal Investigations
☆ New drug approval process funding by prescription drug user fee
☆ Progressive domestic and imports investigation programs by FDA
☆ Quality standards for mammography facilities endorsed by Mammography Quality Act
☆ Reduction in application review times for public healthcare products
☆ Safety information and adverse event reporting program ― MedWatch
☆ Standardization of nutrition facts label as authorized by Nutrition Labeling Act

The Title 21 amendment was signed into law on November 28, 1990, by the 43rd President of the United States George H. W. Bush.

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