Food and Drug Administration Revitalization Act information
Food and Drug Administration Revitalization Act
Long title
An Act to amend the Federal Food, Drug, and Cosmetic Act to revitalize the Food and Drug Administration, and for other purposes.
Nicknames
Food and Drug Administration Revitalization Act of 1990
Enacted by
the 101st United States Congress
Effective
November 28, 1990
Citations
Public law
101-635
Statutes at Large
104 Stat. 4583
Codification
Acts amended
Federal Food, Drug, and Cosmetic Act
Titles amended
21 U.S.C.: Food and Drugs
U.S.C. sections amended
21 U.S.C. ch. 9 § 301 et seq.
21 U.S.C. ch. 9, subch. VII §§ 379b, 379c, 379d
21 U.S.C. ch. 9, subch. X § 394
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 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.[1]
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;[2][3][4]
☆ Digital transformation and Information technology harmonizing FDA as information agency
☆ Enforcement programs streamlined by contingencies of FDA field activities[5][6]
☆ Establishment of Office of Criminal Investigations
☆ New drug approval process funding by prescription drug user fee[7][8]
☆ Progressive domestic and imports investigation programs by FDA[9]
☆ Proposed rule for regulation of tobacco by U.S. FDA[10][11][12]
☆ 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.
^Hatch, Orrin G (1991). "The Future Direction of the Food and Drug Administration". Food, Drug, Cosmetic Law Journal. 46 (1). Food and Drug Law Institute: 15–20. JSTOR 26659270.
^Kessler, David A (January 1991). "Remarks by the Commissioner of Food and Drugs". Food, Drug, Cosmetic Law Journal. 46 (1). Food and Drug Law Institute: 21–26. JSTOR 26659271.
^Kessler, M.D., David A (May 1991). "Responding to the Challenge: A Revitalized FDA". Food, Drug, Cosmetic Law Journal. 46 (3). Food and Drug Law Institute: 391–394. JSTOR 26659032.
^Kessler, M.D., David A (1995). "Remarks by the Commissioner of Food and Drugs". Food and Drug Law Journal. 50 (2). Food and Drug Law Institute: 327–334. JSTOR 26659586.
^Hoeting, Alan L (1991). "The FDA's Philosophy of Enforcement". Food, Drug, Cosmetic Law Journal. 46 (2). Food and Drug Law Institute: 267–272. JSTOR 26659201.
^Hoeting, Alan L (1992). "The FDA's Enforcement Program". Food, Drug, Cosmetic Law Journal. 47 (4). Food and Drug Law Institute: 405–409. JSTOR 26659256.
^Cooper, M.D., Ellen C (1990). "Changes in Normal Drug Approval Process in Response to the AIDS Crisis". Food, Drug, Cosmetic Law Journal. 45 (4). Food and Drug Law Institute: 329–338. JSTOR 26659051.
^Levitt, Joseph A; Kelsey, John V (1993). "The Orphan Drug Regulations and Related Issues". Food and Drug Law Journal. 48 (4). Food and Drug Law Institute: 525–532. JSTOR 26659374.
^Williams, Jr., Troy E (1992). "FDA Investigators and Investigations in the 1990s". Food and Drug Law Journal. 47 (3). Food and Drug Law Institute: 279–286. JSTOR 26659216.
^60 FR 41314
^Hilts, Philip J (April 29, 1994). "Scientists Say Cigarette Company Suppressed Findings on Nicotine". The New York Times.
^Leary, Warren E (June 22, 1994). "Cigarette Company Developed Tobacco With Stronger Nicotine; Head of F.D.A. Tells of Chemical Manipulation". The New York Times.
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