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Volumn 39, Issue 2, 2016, Pages 210-213

The orphan drug act restoring the mission to rare diseases

Author keywords

Health policy; Orphan Drug Act; Orphan drugs; Rare diseases

Indexed keywords

ORPHAN DRUG;

EID: 84947465864     PISSN: 02773732     EISSN: 1537453X     Source Type: Journal    
DOI: 10.1097/COC.0000000000000251     Document Type: Article
Times cited : (50)

References (19)
  • 2
    • 84961938852 scopus 로고    scopus 로고
    • Office of Orphan Products Development. US food and drug administration Accessed February 18, 2015
    • Office of Orphan Products Development. US food and drug administration. Available at: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/Officeof ScienceandHealthCoordination/ucm2018190.htm. Accessed February 18, 2015.
  • 3
    • 84961867475 scopus 로고    scopus 로고
    • US Food and Drug Administration. FAQ Concerning the Orphan Products Grants Program Office of Orphan Products Development Accessed April 24, 2015
    • US Food and Drug Administration. FAQ Concerning the Orphan Products Grants Program, Office of Orphan Products Development. Available at: http://www.fda.gov/ForIndustry/Developing ProductsforRareDiseasesConditions/WhomtoContactaboutOrphan ProductDevelopment/ucm224956.htm. Accessed April 24, 2015.
  • 4
    • 0023176872 scopus 로고
    • Trends in drug development: The 1985-1986 new drug approvals
    • Kaitlin KI, Richard BW, Lasagna L. Trends in drug development: the 1985-1986 new drug approvals. J Clin Pharmacol. 1987;27: 542-548.
    • (1987) J Clin Pharmacol. , vol.27 , pp. 542-548
    • Kaitlin, K.I.1    Richard, B.W.2    Lasagna, L.3
  • 5
    • 0030947897 scopus 로고    scopus 로고
    • The new drug approvals of 1993, 1994, and 1995: Trends in drug development
    • Kaitlin KI, Manocchia M. The new drug approvals of 1993, 1994, and 1995: trends in drug development. Am J Ther. 1997;4:46-54.
    • (1997) Am J Ther. , vol.4 , pp. 46-54
    • Kaitlin, K.I.1    Manocchia, M.2
  • 6
    • 84961886340 scopus 로고    scopus 로고
    • New Drug Approvals in 2011. Presented by America's Biophar-maceutical Research Companies, 2012 Report
    • New Drug Approvals in 2011. Presented by America's Biophar-maceutical Research Companies, 2012 Report.
  • 7
    • 84961870343 scopus 로고    scopus 로고
    • Novel New Drugs 2014 Summary, US Food and Drug Administration: Center for Drug Evaluation and Research, January 2015
    • Novel New Drugs 2014 Summary, US Food and Drug Administration: Center for Drug Evaluation and Research, January 2015.
  • 8
    • 84961888381 scopus 로고    scopus 로고
    • NME Drug and New Biologic Approvals in 2005, US Food and Drug Administration Accessed February 26, 2015
    • NME Drug and New Biologic Approvals in 2005, US Food and Drug Administration. Available at: http://www.fda.gov/Drugs/De velopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ucm081676.htm. Accessed February 26, 2015.
  • 11
    • 84868343934 scopus 로고    scopus 로고
    • Cost-effectiveness of rituximab as maintenance therapy in patients with follicular non-Hodgkins lymphoma after responding to first-line rituximab plus chemotherapy
    • Hornberger J, Chien R, Friedmann M, et al. Cost-effectiveness of rituximab as maintenance therapy in patients with follicular non-Hodgkins lymphoma after responding to first-line rituximab plus chemotherapy. Informa Healthcare. 2012;53:2371-2377.
    • (2012) Informa Healthcare. , vol.53 , pp. 2371-2377
    • Hornberger, J.1    Chien, R.2    Friedmann, M.3
  • 13
    • 84892833525 scopus 로고    scopus 로고
    • New approach to cancer therapy based on a molecularly defined cancer classification
    • Cortes J, Calvo E, Vivancos A, et al. New approach to cancer therapy based on a molecularly defined cancer classification. Cancer J Clin. 2014;64:70-74.
    • (2014) Cancer J Clin. , vol.64 , pp. 70-74
    • Cortes, J.1    Calvo, E.2    Vivancos, A.3
  • 14
    • 84961872774 scopus 로고    scopus 로고
    • American College of Rheumatology. Prevalence Statistics Accessed April 19, 2015. Accessed April 19, 2015
    • American College of Rheumatology. Prevalence Statistics. Available at: http://www.rheumatology.org/Research/Prevalence- Statistics/. Accessed April 19, 2015. Accessed April 19, 2015.
  • 15
    • 84961965406 scopus 로고    scopus 로고
    • The Economic Power of Orphan Drugs, Thomson Reuters, 2012, Food and Drug Administration, HHS. Food and Drug Administration Orphan Drug Regulations, Federal Register Vol. 78, No. 113, June 12, 2013
    • The Economic Power of Orphan Drugs, Thomson Reuters, 2012, Food and Drug Administration, HHS. Food and Drug Administration Orphan Drug Regulations, Federal Register Vol. 78, No. 113, June 12, 2013.
  • 16
    • 84961953133 scopus 로고    scopus 로고
    • Orphan Drug Designations and Approvals List as of September 2, 2014: Governs October 1, 2014-December 31, 2014
    • Orphan Drug Designations and Approvals List as of September 2, 2014: Governs October 1, 2014-December 31, 2014.
  • 17
    • 84857411100 scopus 로고    scopus 로고
    • The prevalence and cost of unapproved uses of top-selling orphan drugs
    • Kesselheim AS, Myers JA, Solomon DH, et al. The prevalence and cost of unapproved uses of top-selling orphan drugs. PLoS ONE. 2012;7:2.
    • (2012) PLoS ONE. , vol.7 , pp. 2
    • Kesselheim, A.S.1    Myers, J.A.2    Solomon, D.H.3
  • 18
    • 84961882966 scopus 로고
    • Washington, DC: Congressional Quarterly Accessed February 4, 2015
    • Bush Pocket-Vetoes Orphan Drug Measure. In CQ Almanac 1990, 46th ed., 577-579. Washington, DC: Congressional Quarterly, 1991. Available at: http://library.cqpress.com/cqalmanac/cqal90-1113412. Accessed February 4, 2015.
    • (1991) Bush Pocket-Vetoes Orphan Drug Measure. in CQ Almanac 1990, 46th Ed. , pp. 577-579
  • 19
    • 84868157585 scopus 로고    scopus 로고
    • Neurology argument against orphan drugs
    • Murphy SM, Puwanant A, Griggs RC, et al. Neurology argument against orphan drugs. Ann Neurol. 2012;72:481-490.
    • (2012) Ann Neurol. , vol.72 , pp. 481-490
    • Murphy, S.M.1    Puwanant, A.2    Griggs, R.C.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.