The prescription drug user fee act of 1992 and the new drug development process

American Journal of Therapeutics

Volumn 4, Issue 5-6, 1997, Pages 167-172

  Kaitin, Kenneth I ^a  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Drug development; Prescription Drug User Fee Act of 1992; US Food and Drug Administration; User fees

Indexed keywords

ARTICLE; DRUG INDUSTRY; DRUG LEGISLATION; FOOD AND DRUG ADMINISTRATION; PRESCRIPTION; PRIORITY JOURNAL; TAX;

EID: 0030951929     PISSN: 10752765     EISSN: None     Source Type: Journal    
DOI: 10.1097/00045391-199705000-00002     Document Type: Article

References (15)

1. Prescription Drug User Fee Act of 1992. Public Law 102-571 (October 29, 1992); 21 USC 379; 106 Stat 4491.
2. Shulman SR, Kaitin KI: The Prescription Drug User Fee Act of 1992: a five-year experiment for industry and the FDA. Pharmacoeconomics 1996;9:121-133.
3. Fourth Annual Performance Report: Prescription Drug User Fee Act of 1992. Fiscal year 1996 report to Congress. Food and Drug Administration, Rockville, MD, December 1996.
4. Harvard Business School: The Food and Drug Administration: Business as Unusual at CDER. (Case Study N9-697-022.) Harvard Business School Publishing, Boston, September 10, 1996.
5. CDER's FY1996 user-fee performance betters FY1995 marks. US Regulatory Reporter 1996;13(5):1-3.
6. US General Accounting Office: FDA User Fees: Current Measures Not Sufficient for Evaluating Effect on Public Health. (GAO/PEMD-94-26.) GAO, Washington, DC, July 1994.
7. DiMasi JA: A new look at U.S. drug development and approval times. Am J Ther 1996;3(9):1-11.
8. 21 CFR 314.101 (a) (1).
9. Third Annual Performance Report: Prescription Drug User Fee Act of 1992. Fiscal year 1994 report to Congress. Food and Drug Administration, Rockville, MD, December 1995.
10. Kuhlik BN: User fees: time for a second look. Regulatory Affairs Focus 1996;1(10):6-7.
11. Kaitin KI: FDA reform: setting the stage for efforts to reform the agency. Drug Inf J 1997;31:27-34.
12. Drug review process "reengineering" unlikely under user fees. U.S. Regulatory Reporter 1993;9(11):6-8.
13. Udin S: User fee talks. BioCentury 1996;4(78):A1-A3.
14. New Drug Evaluation Guidance Document Refusal to File. Food and Drug Administration, Rockville, MD, July 12, 1993.
15. Center for Biologics Evaluation and Research (CBER) Refusal to File (RTF) Guidance for Product License Applications (PLAs) and Establishment License Applications (ELAs). Food and Drug Administration, Rockville, MD, July 12, 1993.