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Volumn 92, Issue 2, 2012, Pages 153-155

Ethical considerations in orphan drug approval and use

Author keywords

[No Author keywords available]

Indexed keywords

GEMTUZUMAB OZOGAMICIN; IMATINIB; MIDODRINE; ORPHAN DRUG;

EID: 84864127384     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2012.92     Document Type: Review
Times cited : (9)

References (10)
  • 2
    • 79958054760 scopus 로고    scopus 로고
    • Innovation and the orphan drug act, 1983-2009: The regulatory and clinical characteristics of approved orphan drugs
    • (eds. Field, M.J. & Boat, T.F.) (National Academy Press, Washington, DC
    • Kesselheim, A.S. Innovation and the Orphan Drug Act, 1983-2009: the regulatory and clinical characteristics of approved orphan drugs. In Accelerating Rare Diseases Research and Orphan Product Development (eds. Field, M.J. & Boat, T.F.) (National Academy Press, Washington, DC, 2010).
    • (2010) Accelerating Rare Diseases Research and Orphan Product Development
    • Kesselheim, A.S.1
  • 3
    • 84864128204 scopus 로고    scopus 로고
    • Title 21 Code Of Federal Regulations, Pt. 314, Sec. 126
    • Adequate and well-controlled studies. Title 21 Code of Federal Regulations, Pt. 314, Sec. 126, 2007.
    • (2007) Adequate and Well-controlled Studies
  • 4
    • 79958036418 scopus 로고    scopus 로고
    • Characteristics of clinical trials to support approval of orphan vs. Nonorphan drugs for cancer
    • Kesselheim, A.S., Myers, J.A. & Avorn, J. Characteristics of clinical trials to support approval of orphan vs. nonorphan drugs for cancer. JAMA 305, 2320-2326 (2011).
    • (2011) JAMA , vol.305 , pp. 2320-2326
    • Kesselheim, A.S.1    Myers, J.A.2    Avorn, J.3
  • 5
  • 6
    • 79958042183 scopus 로고    scopus 로고
    • US Food and Drug Administration 21 June 2010
    • US Food and Drug Administration. Mylotarg (gemtuzumab ozogamicin): market withdrawal 〈http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm216458.htm〉 (21 June 2010).
    • Mylotarg (Gemtuzumab Ozogamicin): Market Withdrawal
  • 7
    • 70349315347 scopus 로고    scopus 로고
    • Accelerated approval of cancer drugs: Improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs?
    • Richey, E.A. et al. Accelerated approval of cancer drugs: improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs? J. Clin. Oncol. 27, 4398-4405 (2009).
    • (2009) J. Clin. Oncol. , vol.27 , pp. 4398-4405
    • Richey, E.A.1
  • 8
    • 77958538769 scopus 로고    scopus 로고
    • F.D.A. Backtracks and returns drug to market
    • 3 September
    • Harris, G. F.D.A. backtracks and returns drug to market. New York Times, 3 September 2010, p. A11.
    • (2010) New York Times
    • Harris, G.1
  • 10
    • 84862150977 scopus 로고    scopus 로고
    • Forbes 22 February
    • Herper, M. The world's most expensive drugs. Forbes, 22 February 2010 〈http://www.forbes. com/2010/02/19/expensive-drugs-costbusiness-healthcare- rare-diseases.html〉.
    • (2010) The World's Most Expensive Drugs
    • Herper, M.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.