Finding value in the U.S. Food and Drug Administration's Fast Track program

Drug News and Perspectives

Volumn 22, Issue 1, 2009, Pages 53-58

  Reichert, Janice M ^a   Rochon, Stephanie L ^a   Zhang, Bodi D ^b  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT; ANTINEOPLASTIC AGENT; IBUPROFEN; MONOCLONAL ANTIBODY; NATURAL PRODUCT; PACLITAXEL; RECOMBINANT PROTEIN; VACCINE;

ARTICLE; DRUG APPROVAL; DRUG CONTROL; DRUG EFFICACY; DRUG INDICATION; DRUG INDUSTRY; DRUG MARKETING; DRUG PROGRAM; DRUG RESEARCH; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE NEED; UNITED STATES;

CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG DESIGN; DRUG INDUSTRY; DRUGS, INVESTIGATIONAL; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 62649118758     PISSN: 02140934     EISSN: None     Source Type: Journal    
DOI: 10.1358/dnp.2009.22.1.1303819     Document Type: Article

References (11)

1. Rutchick, J. and Zeftner, B. FDA's Fast Track designation more help to investors than patients. The Plain Dealer, December 1, 2007. http://blog.cleveland.com/pdworld/2007/12/_a_decade_ago_the.html.
2. Cohen, F.J. The fast track effect. Nat Rev Drug Disc 2004, 3(4): 293-4.
3. Alefantis, T.G., Kulkarni, M.S. and Vora, P.P. Wealth effects of Food and Drug Administration "Fast Track" designation. J Pharma Econ & Policy 2004, 13(3): 41-53.
4. Thaul, S. FDA fast track and priority review programs. CRS Report for Congress, http://nationalaglawcenter.org/assets/crs/RS22814.pdf
5. Milne, C-P. and Bergman, E. Fast track product designotion under the Food and Drug Administration Modernization Act: The industry experience. Drug Inf J 2001, 35(1): 71-83.
6. Milne, C-P. The 4 ages of fast track. Reg Aff Focus 2001, 6(7): 9-13.
7. Tufts Center for the Study of Drug Development Impact Report 2001, 3(1): 1-4.
8. Tufts Center for the Study of Drug Development Impact Report 2003, 5(6): 1-4.
9. Tufts Center for the Study of Drug Development Impact Report 2006, 8(2): 1-4.
10. Tufts Center for the Study of Drug Development Impact Report 2008, 10(5): 1-4.
11. Reichert, J.M. Trends in development and approval times for new therapeutics in the United States. Nat Rev Drug Disc 2003, 2(9): 695-702.