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Volumn 34, Issue 3, 2000, Pages 673-680

Measuring the pace of new drug development in the user fee era

Author keywords

Drug development; FDA Modernization Act of 1997; Food and Drug Administration; New chemical entity; New drug approval; Pharmaceutical industry; Prescription Drug User Fee Act of 1992

Indexed keywords

NEW DRUG;

EID: 0033846522     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150003400303     Document Type: Article
Times cited : (38)

References (12)
  • 1
    • 0008177377 scopus 로고
    • Prescription Drug User Fee Act of 1992. Public Law 102-571; 21 USC 379;106 Stat 4491
    • (1992) , Issue.PART 29
  • 2
    • 0030951929 scopus 로고    scopus 로고
    • The Prescription Drug User Fee Act of 1992 and the new drug development process
    • (1997) Am J Therapeutics , vol.4 , Issue.5-6 , pp. 167-172
    • Kaitin, K.I.1
  • 3
    • 0034045314 scopus 로고    scopus 로고
    • The new drug approvals of 1996, 1997, and 1998: Drug development trends in the user fee era
    • (2000) Drug Inf J , vol.34 , Issue.1 , pp. 1-14
    • Kaitin, K.I.1    Healy, E.M.2
  • 5
    • 0008261331 scopus 로고    scopus 로고
    • Food and Drug Administration Modernization Act of 1997. Public Law 105-115; 21 USC 355a; 111 Stat 2296
    • (1997)
  • 6
    • 0030840825 scopus 로고    scopus 로고
    • Initiatives to speed new drug development and regulatory review: The impact of FDA-sponsor conferences
    • (1997) Drug Inf J , vol.31 , Issue.3 , pp. 771-788
    • DiMasi, J.A.1    Manocchia, M.2
  • 7
    • 0008223187 scopus 로고    scopus 로고
    • Seeking FDA Advice to Speed New Drug Development: The Role of FDA/Sponsor Meetings, a Symposium Organized by the Tufts Center for the Study of Drug Development, January 27, 1999, Philadelphia, PA. Executive Summary. Boston, MA: Tufts CSDD
    • (1999)
  • 8
    • 0008262415 scopus 로고    scopus 로고
    • Effective data use drives portfolio management and global strategies. Boston, MA: Tufts Center for the Study of Drug Development Impact Report
    • (2000) , vol.2 , Issue.1
  • 10
    • 0008220362 scopus 로고    scopus 로고
    • Final annual performance report: Prescription Drug User Fee Act of 1992: fiscal year 1997 report to Congress. Rockville, MD: Food and Drug Administration
    • (1997)
  • 11
    • 0008217932 scopus 로고    scopus 로고
    • FY 1998 performance report to Congress for the Prescription Drug User Fee Act of 1992 as amended by the Food and Drug Administration Modernization Act of 1997
  • 12
    • 0008179707 scopus 로고    scopus 로고
    • Pharma 2005: an industrial revolution in R and D. London: PriceWaterhouseCoopers
    • (1998)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.