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Volumn 34, Issue 1, 2000, Pages 295-300

The orphan drug act: Provisions and considerations

Author keywords

Drug development; Orphan Drug Act; Rare diseases

Indexed keywords

ORPHAN DRUG;

EID: 0034086889     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150003400137     Document Type: Article
Times cited : (2)

References (21)
  • 1
    • 0342556547 scopus 로고
    • The US Orphan Drug Act: Should the law cover higher profitable drugs?
    • Meyers AS. The US Orphan Drug Act: Should the law cover higher profitable drugs? World Pharmaceut. Standards Rev. 1991;1:24-25.
    • (1991) World Pharmaceut. Standards Rev , vol.1 , pp. 24-25
    • Meyers, A.S.1
  • 2
    • 0030276363 scopus 로고    scopus 로고
    • Orphan drugs: A problem of public health and an economic stake
    • Brandissou S, Yagoubi N, Hasselot N. Orphan Drugs: a problem of public health and an economic stake. Therapie. 1996;51:647-653.
    • (1996) Therapie , vol.51 , pp. 647-653
    • Brandissou, S.1    Yagoubi, N.2    Hasselot, N.3
  • 3
    • 0026439799 scopus 로고
    • Implementation of the Orphan Drug Act: 1998-1991
    • Shulman SR, Bienz-Tadmor B, Seo PS et al. Implementation of the Orphan Drug Act: 1998-1991. Food Drug Law J. 1992;47(4):363-403.
    • (1992) Food Drug Law J , vol.47 , Issue.4 , pp. 363-403
    • Shulman, S.R.1    Bienz-Tadmor, B.2    Seo, P.S.3
  • 4
    • 0027913313 scopus 로고
    • 1993 revised classification system for HIV infection and expnaded surveillance case definitions for AIDS among adolescents and adults
    • Centers for Disease Control and Prevention. 1993 revised classification system for HIV infection and expnaded surveillance case definitions for AIDS among adolescents and adults. JAMA. 1993;269(6): 729-730.
    • (1993) JAMA , vol.269 , Issue.6 , pp. 729-730
  • 5
    • 0028373989 scopus 로고
    • Benefits versus profits - Has the Orphan Drug Act gone too far?
    • Garber A. Benefits versus profits - has the Orphan Drug Act gone too far? Pharmacoeconomics. 1994; 5(2):88-92.
    • (1994) Pharmacoeconomics , vol.5 , Issue.2 , pp. 88-92
    • Garber, A.1
  • 6
    • 0342556546 scopus 로고    scopus 로고
    • 21 Code of Federal Regulations (CFR) 316.2
    • 21 Code of Federal Regulations (CFR) 316.2.
  • 7
    • 0028788896 scopus 로고
    • The economics of orphan drug policy in the US - Can the legislation be improved?
    • Peabody JW, Ruby A, Cannon P. The economics of orphan drug policy in the US - Can the legislation be improved? Pharmacoeconomics. 1995;8(5):874-884.
    • (1995) Pharmacoeconomics , vol.8 , Issue.5 , pp. 874-884
    • Peabody, J.W.1    Ruby, A.2    Cannon, P.3
  • 8
    • 0029183838 scopus 로고
    • Rare disease, drug development, and AIDS: The impact of the Orphan Drug Act
    • Arno PS, Bonuck K, Davis M. Rare disease, drug development, and AIDS: the impact of the Orphan Drug Act. Milbank Quarterly. 1995;73(2):231-252.
    • (1995) Milbank Quarterly , vol.73 , Issue.2 , pp. 231-252
    • Arno, P.S.1    Bonuck, K.2    Davis, M.3
  • 9
    • 0031038983 scopus 로고    scopus 로고
    • The United States Orphan Drug Act: Challenges and successes
    • Haffner ME. The United States Orphan Drug Act: Challenges and successes. Drug Inf. J. 1997;31: 23-25.
    • (1997) Drug Inf J , vol.31 , pp. 23-25
    • Haffner, M.E.1
  • 10
    • 0342990771 scopus 로고    scopus 로고
    • Tufts Center for the Study of Drug Development
    • Tufts Center for the Study of Drug Development.
  • 11
    • 0342556543 scopus 로고    scopus 로고
    • note
    • Statements by Michael Friedman, Deputy Commissioner for Operations, Food and Drug Administration, Department of Health and Human Services. Before the Subcommittee on Human Resources and Intergovernmental Relations, Committee on Government Reform and Oversight, U.S. House of Representatives; Sept 12, 1996.
  • 12
    • 0026448022 scopus 로고
    • Evaluation of orphan products by the US Food and Drug Administration
    • Haffner ME, Kelsey JV. Evaluation of orphan products by the US Food and Drug Administration. Int J Technol Assess Health Care. 1992;8(4):647-657.
    • (1992) Int J Technol Assess Health Care , vol.8 , Issue.4 , pp. 647-657
    • Haffner, M.E.1    Kelsey, J.V.2
  • 14
    • 0343426342 scopus 로고
    • Orphan Drug Regulations: Final Rule
    • 21 Code of Federal Regulations (CFR) Part 316 December 29
    • 21 Code of Federal Regulations (CFR) Part 316. Orphan Drug Regulations: Final Rule; Federal Register. December 29, 1992.
    • (1992) Federal Register
  • 15
    • 0029958144 scopus 로고    scopus 로고
    • Orphan Drug Act of 1983
    • Spilker B. Orphan Drug Act of 1983. Drug News Perspectives. 1996;9(8):460-462.
    • (1996) Drug News Perspectives , vol.9 , Issue.8 , pp. 460-462
    • Spilker, B.1
  • 16
    • 0031046571 scopus 로고    scopus 로고
    • Orphan drugs: The current situation in the United States, Europe, and Asia
    • Myers A. Orphan drugs: The current situation in the United States, Europe, and Asia. Drug Inf J. 1997; 31(1):101-104.
    • (1997) Drug Inf J , vol.31 , Issue.1 , pp. 101-104
    • Myers, A.1
  • 17
    • 0342990769 scopus 로고    scopus 로고
    • 21 Code of Federal Regulations (CFR) 316,316.3(b) (12,13)
    • 21 Code of Federal Regulations (CFR) 316,316.3(b) (12,13).
  • 19
    • 0031942634 scopus 로고    scopus 로고
    • Orphan Drug development - International program and study design issues
    • Haffner ME. Orphan Drug development - International program and study design issues. Drug Inf J. 1998;32:93-99.
    • (1998) Drug Inf J , vol.32 , pp. 93-99
    • Haffner, M.E.1
  • 20
    • 0030882809 scopus 로고    scopus 로고
    • The US Orphan Drug Programme 1983-1995
    • Shulman SR, Manocchia M. The US Orphan Drug Programme 1983-1995. Pharmacoeconomics. 1997; 12(3):312-326.
    • (1997) Pharmacoeconomics , vol.12 , Issue.3 , pp. 312-326
    • Shulman, S.R.1    Manocchia, M.2
  • 21
    • 0027567757 scopus 로고
    • Orphan products: Drugs and devices for rare diseases
    • Pillar B. Orphan Products: drugs and devices for rare diseases. Nursing Econ. 1993:11(2):99-102.
    • (1993) Nursing Econ , vol.11 , Issue.2 , pp. 99-102
    • Pillar, B.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.