FDA reform: Setting the stage for efforts to reform the agency

Drug Information Journal

Volumn 31, Issue 1, 1997, Pages 27-33

  Kaitin, Kenneth I ^a  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Congress; Drug development; FDA reform; Foreign marketing; Phase 1

Indexed keywords

DRUG DEVELOPMENT; DRUG INDUSTRY; DRUG MARKETING; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; PRIORITY JOURNAL; REVIEW;

EID: 0031050791     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159703100105     Document Type: Review

References (16)

1. FDA Performance and Accountability Act of 1995 (S 1477).
2. Drug and Biological Products Reform Act of 1996 (HR 3199).
3. Clinton B, Gore A. National performance review: reinventing government. Washington DC: The White House; 1995.
4. New Drug Regulatory Improvement Act of 1995 (draft document June 14, 1995). Washington, DC: Pharmaceutical Research and Manufacturers of America; 1995.
5. FDA regulatory reform: a proposal by the Biotechnology Industry Organization. Concept Paper: 2/27/ 95. Washington, DC: BIO; 1995.
6. Clinton B, Gore A. Reinventing the regulation of cancer drugs. Washington, DC: The White House; March 29, 1996.
7. DiMasi JA, Seibring MA, Lasagna L. New drug development in the United States 1963 to 1992. Clin Pharmacol Ther. 1994 Jun;55(6):609-622.
8. Shulman SR, Kaitin KI. The Prescription Drug User Fee Act of 1992: A five-year experiment for industry and the FDA. Pharmaco Econ. 1996 Feb; 9(2): 121-133.
9. Kaitin KI. Pharmaceutical innovation in a changing environment. Part II Chapter 7 in Contested ground: public purpose and private interest in the regulation of prescription drugs. Davis P ed. New York: Oxford University Press; 1996:109-123.
10. Cullen R. Pharmaceuticals inter-country diffusion. Manag Decision Econ. 1983;4:73-82.
11. Kaitin KI, Mattison N, Northington FK, Lasagna L. The drug lag: an update of new drug introductions in the United States and the United Kingdom, 1977 through 1987. Clin Pharmacol Therapeut. 1989; 46(2):121-138.
12. Wardell WM. Introduction of new therapeutic drugs in the United States and Great Britain: an international comparison. Clin Pharmacol Ther. 1973 Sep-Oct: 14(5)773-790.
13. Kessler DA. Remarks at the Food and Drug Law Institute Annual Meeting. Washington DC, December 12. 1995. and Kessler DA Haas AE Fieden KL Lumpkin M Temple R. America's rapid access to new drugs: an international comparison. JAMA. 1997.
14. Kessler DA. Remarks at the Food and Drug Law Institute Annual Meeting. Washington DC, December 12. 1995. and Kessler DA Haas AE Fieden KL Lumpkin M Temple R. America's rapid access to new drugs: an international comparison. JAMA. 1997.
15. FDA drug approval: review time has decreased in recent years. (GAO/PMED-96-1) Washington, DC: U.S. General Accounting Office; October 1995.
16. Third annual performance report: Prescription Drug User Fee Act of 1992: Fiscal Year 1995 Report to Congress. Rockville, MD: Food and Drug Administration; December 1995.