Fast track product designation under the food and drug administration modernization act: The industry experience

Drug Information Journal

Volumn 35, Issue 1, 2001, Pages 71-83

  Milne, C P ^a   Bergman, E ^a  

^a TUFTS UNIVERSITY   (United States)

Author keywords

Accelerated approval; Expedited development; Fast track; Fast track designation; FDA Modernization Act; FDA sponsor meetings; FDAMA; Food and Drug Administration; Priority review; Rolling review

Indexed keywords

BIOTECHNOLOGY; DRUG DESIGN; DRUG INDUSTRY; DRUG INFORMATION; DRUG PROGRAM; FOOD AND DRUG ADMINISTRATION; HEALTH PROGRAM; INFORMATION SERVICE; PRIORITY JOURNAL; REVIEW;

EID: 0035095214     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150103500108     Document Type: Review

References (15)

1. Another view on industry response to fast track program
2. Drug industry has not yet embraced FDAMA's "Fast Track" program
3. An interview with director of the Division of Cardio-renal Drug Products Raymond Lipicky, M.D.
4. PhRMA proposals for fast-track products
5. The Food and Drug Administration's early access and fast-track approval initiatives: How have they worked?
6. Faster access to drugs for serious or life-threatening illnesses through the use of the accelerated approval regulation in the United States
7. Initiatives to speed new drug development and regulatory review: The impact of FDA-sponsor conferences
8. Fast Track
9. An analysis of the FDA's fast track initiative, March 2000
10. The ABC's of interaction with the FDA