The Effects of the Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act on the Development and Approval of Therapeutic Medicines

Author:

Reichert Janice M.,Chee Jennifer,Kotzampaltiris Claire S.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug guides,Pharmacology (nursing)

Reference11 articles.

1. Prescription Drug User Fee Act of 1992. US Public Law 102–571 (1992 Oct 29); 21 USC 379; 106 Stat 4491.

2. Food and Drug Administration Modernization Act of 1997. US Public Law 105–115 (1997 Nov 21); 21 USC 355a; 111 Stat 2296.

3. Shulman SR, Kaitin KI. The Prescription Drug User Fee Act of 1992: a five-year experiment for industry and the FDA. Pharmacoeconomics. 1996 Feb;9(2):121–133.

4. Kuhlik BN. The U. Food and Drug Administration Modernization Act of 1997 (Part one). Bio-Science Law Review 1997;4:127–140.

5. Progress in achieving the performance goals referenced in the Prescription Drug User Fee Act of 1992. First Report to Congress for the Period September 1,1992 through September 30, 7993. Rockville, MD: US Food and Drug Administration; April 1994.

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