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

Therapeutic Innovation & Regulatory Science

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

  Milne, Christopher Paul ^a   Bergman, Elaine ^a  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (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

EID: 84996211661     PISSN: 21684790     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150103500108     Document Type: Article

References (15)

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12. Risso ST Fast track and priority review from the FDA perspective. www.fda.gov/cber/gdlns/fsttrk.pdf.
13. Senate Committee on Labor and Human Resources. Food and Drug Administration Modernization and Accountability Act of 1997 Senate Report 107–43, to accompany S830. 105th Congress 1st Session. Washington, DC: US Government Printing Office; 1997.
14. House Committee on Commerce. Prescription Drug User Fee Reauthorization and Drug Regulatory Modernization Act of 1997. House Report 105–310, to accompany HR 1411. 105th Congress 1st Session. Washington, DC: US Government Printing Office; 1997.
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