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.
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;
Elements of Food and Drug Administration Revitalization
- 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
- Proposed rule for regulation of tobacco by U.S. FDA
- Quality standards for mammography facilities endorsed by Mammography Quality Act
- Reduction in application, IND, and NDA review times for healthcare products
- Safety information and adverse event reporting program ― MedWatch
- Standardization of nutrition facts label as authorized by Nutrition Labeling Act
Provisions of the Act
The Food and Drug Administration Revitalization Act of 1990 was penned with four legislative titles establishing a medium for the rejuvenation of the public health agency.Title I: Administrative and Laboratory Facility Consolidation - 21 U.S.C. § 379b
Title II: Recovery and Retention of Fees for FOIA Requests - 21 U.S.C. § 379c
Title III: Scientific Review Groups - 21 U.S.C. § 394
Title IV: Automation of FDA - ''21 U.S.C. § 379d''