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Volumn 36, Issue 2, 2002, Pages 291-302

The single controlled trial: Industry survey indicates that implementation is still a work in progress

Author keywords

Effectiveness; Food and Drug Administration Modernization Act of 1997; Single controlled trial

Indexed keywords

BIOTECHNOLOGY; CLINICAL TRIAL; CONFERENCE PAPER; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG LEGISLATION; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; PRIORITY JOURNAL;

EID: 0036376717     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150203600207     Document Type: Conference Paper
Times cited : (6)

References (15)
  • 1
    • 0032962976 scopus 로고    scopus 로고
    • Will FDA relinquish the "gold standard" for new drug approval? Redefining "substantial evidence" in the FDA Modernization Act of 1997
    • Kulynych J. Will FDA relinquish the "gold standard" for new drug approval? Redefining "substantial evidence" in the FDA Modernization Act of 1997. Food Drug Law J. 1999;54(1):127-149.
    • (1999) Food Drug Law J , vol.54 , Issue.1 , pp. 127-149
    • Kulynych, J.1
  • 4
    • 0010334641 scopus 로고    scopus 로고
    • Food and Drug Administration Modernization Act of 1997. Pub Law 105-115 (1997 Nov 21); 21 USC 355a; 111 Stat. 2296
    • Food and Drug Administration Modernization Act of 1997. Pub Law 105-115 (1997 Nov 21); 21 USC 355a; 111 Stat. 2296.
  • 5
    • 0010333353 scopus 로고    scopus 로고
    • House Report 105-310, to accompany H.R. 1411. Prescription Drug Modernization Act of 1997. October 7, 1997. 105th Congress, 1st Session
    • House Report 105-310, to accompany H.R. 1411. Prescription Drug Modernization Act of 1997. October 7, 1997. 105th Congress, 1st Session.
  • 6
    • 0010381058 scopus 로고    scopus 로고
    • PDUFA III could move through Congress in 2001, Rep. Burr suggests
    • May 7
    • PDUFA III could move through Congress in 2001, Rep. Burr suggests. Pink Sheet. 2001 May 7;63(19): 3-4.
    • (2001) Pink Sheet , vol.63 , Issue.19 , pp. 3-4
  • 8
    • 0010413876 scopus 로고    scopus 로고
    • Clinical development times for new drugs drop 18%, reversing 12-yr trend
    • Boston, MA: Tufts Center for the Study of Drug Development; July
    • Clinical development times for new drugs drop 18%, reversing 12-yr trend. Impact Report. Boston, MA: Tufts Center for the Study of Drug Development; July 1999.
    • (1999) Impact Report
  • 10
    • 0010413878 scopus 로고    scopus 로고
    • New paradigms for clinical development of biologic products
    • August
    • New paradigms for clinical development of biologic products. Biotechnology Law Report. August 1999; 328(4):18.
    • (1999) Biotechnology Law Report , vol.328 , Issue.4 , pp. 18
  • 11
    • 0031894352 scopus 로고    scopus 로고
    • Faster access to drugs for serious or life-threatening illnesses through the use of the accelerated approval regulation in the United States
    • Cocchetto DM, Jones DR. Faster access to drugs for serious or life-threatening illnesses through the use of the accelerated approval regulation in the United States. Drug Inf J. 1998;32(1):27-35.
    • (1998) Drug Inf J , vol.32 , Issue.1 , pp. 27-35
    • Cocchetto, D.M.1    Jones, D.R.2
  • 14
    • 13144292424 scopus 로고    scopus 로고
    • Nov. 21
    • FDA Backgrounder: The FDA Modernization Act of 1997. Nov. 21, 1997. http://www.fda.gov/opacom/backgrounders/modact.htm.
    • (1997) The FDA Modernization Act of 1997


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.