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Volumn 96, Issue 5, 2014, Pages 559-571

Accelerated access to innovative medicines for patients in need

(14)  Baird, L G a   Banken, R b   Eichler, H G c   Kristensen, F B d   Lee, D K e   Lim, J C W f   Lim, R e   Longson, C g   Pezalla, E h   Salmonson, T i   Samaha, D b   Tunis, S j   Woodcock, J k   Hirsch, G a  


Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CANADA; EUROPEAN; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH CARE ACCESS; HEALTH CARE NEED; HEALTH CARE QUALITY; HEALTH TECHNOLOGY ASSESSMENT; HUMAN; INNOVATIVE MEDICINE; MEDICARE; MEDICINE; PATIENT CARE; REIMBURSEMENT; SINGAPORE; UNITED STATES; HEALTH CARE DELIVERY; HEALTH SERVICE; MEDICAL TECHNOLOGY; SUPPLY AND DISTRIBUTION;

EID: 84908203910     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2014.145     Document Type: Article
Times cited : (68)

References (31)
  • 1
    • 85054115968 scopus 로고    scopus 로고
    • US Food and Drug Administration. Reports on post-marketing studies [FDAMA. Accessed 6 November 2013
    • US Food and Drug Administration. Reports on post-marketing studies [FDAMA 130].
    • , vol.130
  • 2
    • 84892390898 scopus 로고    scopus 로고
    • Development times, clinical testing, post-market follow-up, and safety risks for the new drugs approved by the US Food and Drug Administration
    • Moore, T. J. & Furberg, C. D. Development times, clinical testing, post-market follow-up, and safety risks for the new drugs approved by the US Food and Drug Administration. JAMA Intern Med. 174, 90-95 (2014).
    • (2014) JAMA Intern Med. , vol.174 , pp. 90-95
    • Moore, T.J.1    Furberg, C.D.2
  • 5
    • 85054114436 scopus 로고    scopus 로고
    • E ngelberg Center for Health Care Reform. Special medical use: limited use for drugs developed in an expedited manner to meet an unmet medical need. Accessed 4 November 2013
    • E ngelberg Center for Health Care Reform. Special medical use: limited use for drugs developed in an expedited manner to meet an unmet medical need.
    • (2013)
  • 9
    • 85054114121 scopus 로고    scopus 로고
    • E uropean Medicines Agency (2012). Accessed 31 July 2013
    • E uropean Medicines Agency. Work programme 2013.
    • Work Programme 2013
  • 10
    • 85054114509 scopus 로고    scopus 로고
    • E uropean Medicines Agency. Press release: European Medicines Agency launches adaptive licensing pilot project Accessed 19 March 2014
    • E uropean Medicines Agency. Press release: European Medicines Agency launches adaptive licensing pilot project.
    • (2014)
  • 13
    • 84862777400 scopus 로고    scopus 로고
    • Adaptive licensing: Taking the next step in the evolution of drug approval
    • E ichler, H. G. et al. Adaptive licensing: taking the next step in the evolution of drug approval. Clin. Pharmacol. Ther. 91, 426-437 (2012).
    • (2012) Clin. Pharmacol. Ther. , vol.91 , pp. 426-437
    • Ichler, E.G.H.1
  • 14
    • 84883167013 scopus 로고    scopus 로고
    • Legal foundations of adaptive licensing
    • Oye, K. et al. Legal foundations of adaptive licensing. Clin. Pharmacol. Ther. 94, 309-311 (2013).
    • (2013) Clin. Pharmacol. Ther. , vol.94 , pp. 309-311
    • Oye, K.1
  • 17
    • 33749361745 scopus 로고    scopus 로고
    • Medicare's coverage of colorectal cancer drugs: A case study in evidence development and policy
    • Carino, T., Williams, R. D. 2nd, Colbert, A. M. & Bridger, P. Medicare's coverage of colorectal cancer drugs: a case study in evidence development and policy. Health Aff. (Millwood). 25, 1231-1239 (2006).
    • (2006) Health Aff. (Millwood). , vol.25 , pp. 1231-1239
    • Carino, T.1    Williams, R.D.2    Colbert, A.M.3    Bridger, P.4
  • 18
    • 75749146191 scopus 로고    scopus 로고
    • Access with evidence development: The US experience
    • Mohr, P. E. & Tunis, S. R. Access with evidence development: the US experience. Pharmacoeconomics 28, 153-162 (2010).
    • (2010) Pharmacoeconomics , vol.28 , pp. 153-162
    • Mohr, P.E.1    Tunis, S.R.2
  • 19
    • 33749332084 scopus 로고    scopus 로고
    • Coverage options for promising technologies: Medicare's 'coverage with evidence development'
    • Tunis, S. R. & Pearson, S. D. Coverage options for promising technologies: Medicare's 'coverage with evidence development'. Health Aff. (Millwood). 25, 1218-1230 (2006).
    • (2006) Health Aff. (Millwood). , vol.25 , pp. 1218-1230
    • Tunis, S.R.1    Pearson, S.D.2
  • 20
    • 75149145199 scopus 로고    scopus 로고
    • European network for Health Technology Assessment (EUnetHTA). A common policy framework for evidence generation on promising health technologies
    • Carbonneil, C., Quentin, F. & Lee-Robin, S. H.; European network for Health Technology Assessment (EUnetHTA). A common policy framework for evidence generation on promising health technologies. Int. J. Technol. Assess. Health Care 25 (suppl. 2), 56-67 (2009).
    • (2009) Int. J. Technol. Assess. Health Care , vol.25 , pp. 56-67
    • Carbonneil, C.1    Quentin, F.2    Lee-Robin, S.H.3
  • 22
    • 79955701065 scopus 로고    scopus 로고
    • HTAi Policy Forum. What principles should govern the use of managed entry agreements
    • Klemp, M., Frønsdal, K. B. & Facey, K.; HTAi Policy Forum. What principles should govern the use of managed entry agreements? Int. J. Technol. Assess. Health Care 27, 77-83 (2011).
    • (2011) Int. J. Technol. Assess. Health Care , vol.27 , pp. 77-83
    • Klemp, M.1    Frønsdal, K.B.2    Facey, K.3
  • 23
    • 75149182918 scopus 로고    scopus 로고
    • European network for Health Technology Assessment (EUnetHTA). Practical tools and methods for health technology assessment in Europe: Structures, methodologies, and tools developed by the European Network for Health Technology Assessment
    • Kristensen, F. B. et al.; European network for Health Technology Assessment (EUnetHTA). Practical tools and methods for health technology assessment in Europe: structures, methodologies, and tools developed by the European Network for Health Technology Assessment, EUnetHTA. Int. J. Technol. Assess. Health Care 25 (suppl. 2), 1-8 (2009).
    • (2009) EUnetHTA Int. J. Technol. Assess. Health Care , vol.25 , pp. 1-8
    • Kristensen, F.B.1
  • 25
    • 75149196907 scopus 로고    scopus 로고
    • European network for Health Technology Assessment (EUnetHTA). Web-based toolkit to facilitate European collaboration on evidence generation on promising health technologies
    • Quentin, F., Carbonneil, C., Moty-Monnereau, C., Berti, E., Goettsch, W. & Lee-Robin, S. H.; European network for Health Technology Assessment (EUnetHTA). Web-based toolkit to facilitate European collaboration on evidence generation on promising health technologies. Int. J. Technol. Assess. Health Care 25 (suppl. 2), 68-74 (2009).
    • (2009) Int. J. Technol. Assess. Health Care , vol.25 , pp. 68-74
    • Quentin, F.1    Carbonneil, C.2    Moty-Monnereau, C.3    Berti, E.4    Goettsch, W.5    Lee-Robin, S.H.6
  • 26
    • 85054113926 scopus 로고    scopus 로고
    • E uropean network for Health Technology Assessment Accessed 31 July 2013
    • E uropean network for Health Technology Assessment. EVIDENT Database. . Accessed 31 July 2013.
    • EVIDENT Database
  • 27
    • 85054116092 scopus 로고    scopus 로고
    • E uropean Commission. High Level Pharmaceutical Forum 2005-2008: Final Conclusions and Recommendations. Accessed 31 July 2013
    • E uropean Commission. High Level Pharmaceutical Forum 2005-2008: Final Conclusions and Recommendations. . Accessed 31 July 2013.
  • 28
    • 85054114327 scopus 로고    scopus 로고
    • E uropean network for Health Technology Assessment. Joint EUnetHTA-EMA Press Release
    • E uropean network for Health Technology Assessment. Joint EUnetHTA-EMA Press Release. (2013).
    • (2013)
  • 29
    • 85054109706 scopus 로고    scopus 로고
    • US Food and Drug Administration. FY 2012 Innovative Drug Approvals Accessed 13 November 2013
    • US Food and Drug Administration. FY 2012 Innovative Drug Approvals. (2012). Accessed 13 November 2013.
    • (2012)
  • 31
    • 75149130069 scopus 로고    scopus 로고
    • A flexible blueprint for the future of drug development
    • Barker, R. A flexible blueprint for the future of drug development. Lancet 374, 357-359 (2010).
    • (2010) Lancet , vol.374 , pp. 357-359
    • Barker, R.1


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