메뉴 건너뛰기




Volumn 73, Issue SUPPL.1, 2013, Pages

FDA decisions and public deliberation: Challenges and opportunities

Author keywords

[No Author keywords available]

Indexed keywords


EID: 84884355810     PISSN: 00333352     EISSN: 15406210     Source Type: Journal    
DOI: 10.1111/puar.12121     Document Type: Article
Times cited : (22)

References (72)
  • 1
    • 34247188454 scopus 로고    scopus 로고
    • Bringing "the Public" into Health Technology Assessment and Coverage Policy Decisions: From Principles to Practice
    • Abelson, Julia, Mita Giacomini, Pascale Lehoux, and François-Pierre Gauvin 2007. Bringing "the Public" into Health Technology Assessment and Coverage Policy Decisions: From Principles to Practice. Health Policy 82(1): 37-50.
    • (2007) Health Policy , vol.82 , Issue.1 , pp. 37-50
    • Abelson, J.1    Giacomini, M.2    Lehoux, P.3    Gauvin, F.-P.4
  • 2
    • 84884355144 scopus 로고    scopus 로고
    • Measuring Conflict of Interest and Expertise on FDA Advisory Committees. Report submitted to the Office of Policy, Planning and Preparedness, U.S. Food and Drug Administration, October 26. [accessed July 24, 2013].
    • Ackerley, Nyssa, John Eyraud, and Marisa Mazzotta 2007. Measuring Conflict of Interest and Expertise on FDA Advisory Committees. Report submitted to the Office of Policy, Planning and Preparedness, U.S. Food and Drug Administration, October 26. http://www.fda.gov/oc/advisory/ergcoireport.pdf [accessed July 24, 2013].
    • (2007)
    • Ackerley, N.1    Eyraud, J.2    Mazzotta, M.3
  • 5
    • 2642555263 scopus 로고    scopus 로고
    • with Washington, DC: Brookings Institution Press.
    • Berry, Jeffrey M., with David F. Arons 2003. A Voice for Nonprofits. Washington, DC: Brookings Institution Press.
    • (2003) A Voice for Nonprofits
    • Berry, J.M.1    Arons, D.F.2
  • 7
    • 0036323966 scopus 로고    scopus 로고
    • Groups, the Media, Agency Waiting Costs, and FDA Drug Approval
    • Carpenter, Daniel. 2002. Groups, the Media, Agency Waiting Costs, and FDA Drug Approval. American Journal of Political Science 46(3): 490-505.
    • (2002) American Journal of Political Science , vol.46 , Issue.3 , pp. 490-505
    • Carpenter, D.1
  • 9
    • 84855922099 scopus 로고    scopus 로고
    • The Complications of Controlling Agency Time Discretion: FDA Review Deadlines and Postmarket Drug Safety
    • Carpenter, Daniel, Jacqueline Chattopadhyay, Susan Moffitt, and Clayton Nall 2012. The Complications of Controlling Agency Time Discretion: FDA Review Deadlines and Postmarket Drug Safety. American Journal of Political Science 56(1): 98-114.
    • (2012) American Journal of Political Science , vol.56 , Issue.1 , pp. 98-114
    • Carpenter, D.1    Chattopadhyay, J.2    Moffitt, S.3    Nall, C.4
  • 11
    • 3142664780 scopus 로고    scopus 로고
    • Public Deliberation, Discursive Participation, and Citizen Engagement: A Review of the Empirical Literature
    • Cook, and Lawrence R. Jacobs
    • Carpini, Michael X. Delli, Fay Lomax Cook, and Lawrence R. Jacobs. 2004. Public Deliberation, Discursive Participation, and Citizen Engagement: A Review of the Empirical Literature. Annual Review of Political Science 7: 315-44.
    • (2004) Annual Review of Political Science , vol.7 , pp. 315-344
    • Carpini, M.X.1    Delli, F.L.2
  • 13
    • 79960498401 scopus 로고    scopus 로고
    • Desperately Seeking Cancer Drugs: Explaining the Emergence and Outcomes of Accelerated Pharmaceutical Regulation
    • Davis, Courtney, and John Abraham 2011. Desperately Seeking Cancer Drugs: Explaining the Emergence and Outcomes of Accelerated Pharmaceutical Regulation. Sociology of Health and Illness 33(5): 731-47.
    • (2011) Sociology of Health and Illness , vol.33 , Issue.5 , pp. 731-747
    • Davis, C.1    Abraham, J.2
  • 15
    • 84873842723 scopus 로고    scopus 로고
    • Global Democratization: Soup, Society, or System?
    • Dryzek, John S. 2011. Global Democratization: Soup, Society, or System? Ethics and International Affairs 25(2): 211-34.
    • (2011) Ethics and International Affairs , vol.25 , Issue.2 , pp. 211-234
    • Dryzek, J.S.1
  • 20
    • 84884353037 scopus 로고    scopus 로고
    • Pain Foundation's Drug Money Was a Shame, but So Is Group's Demise. CommonHealth, May 9. [accessed July 24, 2013].
    • Foreman, Judy. 2012. Pain Foundation's Drug Money Was a Shame, but So Is Group's Demise. CommonHealth, May 9. http://commonhealth.wbur.org/2012/05/judy-foreman-pain-foundation [accessed July 24, 2013].
    • (2012)
    • Foreman, J.1
  • 25
    • 84884357582 scopus 로고    scopus 로고
    • Evidence and Fear: Navigating the Politics of Evidence Based Medicine. AcademyHealth Reports, June 1. [accessed July 24, 2013].
    • Gusmano, Michael K., and Bradford H. Gray 2010. Evidence and Fear: Navigating the Politics of Evidence Based Medicine. AcademyHealth Reports, June 1. http://www.academyhealth.org/evidenceandfear [accessed July 24, 2013].
    • (2010)
    • Gusmano, M.K.1    Gray, B.H.2
  • 31
    • 0037219184 scopus 로고    scopus 로고
    • Health Care Reform and Social Movements in the United States
    • Hoffman, Beatrice. 2003. Health Care Reform and Social Movements in the United States. American Journal of Public Health 93(1): 75-85.
    • (2003) American Journal of Public Health , vol.93 , Issue.1 , pp. 75-85
    • Hoffman, B.1
  • 33
    • 84884355343 scopus 로고    scopus 로고
    • FDA Issues Final Guidance on Factors to Consider When Making Benefit-Risk Determinations in Premarket Approval and De Novo Classifications. King & Spalding Client Alert, April 25. [accessed July 24, 2013].
    • King & Spalding. 2012. FDA Issues Final Guidance on Factors to Consider When Making Benefit-Risk Determinations in Premarket Approval and De Novo Classifications. King & Spalding Client Alert, April 25. http://www.kslaw.com/imageserver/KSPublic/library/publication/ca042512.pdf [accessed July 24, 2013].
    • (2012)
    • King, S.1
  • 34
    • 79953679877 scopus 로고    scopus 로고
    • Federal Advisory Committees, Policy Expertise, and the Approval of Drugs and Medical Devices at the FDA
    • Lavertu, Stéphane, and David L. Weimer 2001. Federal Advisory Committees, Policy Expertise, and the Approval of Drugs and Medical Devices at the FDA. Journal of Public Administration Research and Theory 21(2): 211-37.
    • (2001) Journal of Public Administration Research and Theory , vol.21 , Issue.2 , pp. 211-237
    • Lavertu, S.1    Weimer, D.L.2
  • 36
    • 0004230079 scopus 로고
    • Chicago: Rand McNally.
    • Long, Norton E. 1962. The Polity. Chicago: Rand McNally.
    • (1962) The Polity
    • Long, N.E.1
  • 37
    • 33646149764 scopus 로고    scopus 로고
    • Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings
    • Lurie, Peter, Cristina M. Almeida, Nicholas Stine, Alexander R. Stine, and Sidney M. Wolfe 2006. Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings. Journal of the American Medical Association 295(16): 1921-28.
    • (2006) Journal of the American Medical Association , vol.295 , Issue.16 , pp. 1921-1928
    • Lurie, P.1    Almeida, C.M.2    Stine, N.3    Stine, A.R.4    Wolfe, S.M.5
  • 39
    • 84868628208 scopus 로고    scopus 로고
    • The Effect of Salient Reputational Threats on the Pace of FDA Enforcement
    • Maor, Moshe, and Raanan Sulitzeanu-Kenan 2013. The Effect of Salient Reputational Threats on the Pace of FDA Enforcement. Governance 26(1): 31-61.
    • (2013) Governance , vol.26 , Issue.1 , pp. 31-61
    • Maor, M.1    Sulitzeanu-Kenan, R.2
  • 40
    • 79953012559 scopus 로고    scopus 로고
    • Doing More with Less? Past and Present Challenges for the FDA
    • McCain, Jack. 2011. Doing More with Less? Past and Present Challenges for the FDA. Pharmacy and Therapeutics 36(3): 145-55.
    • (2011) Pharmacy and Therapeutics , vol.36 , Issue.3 , pp. 145-155
    • McCain, J.1
  • 41
    • 79952035501 scopus 로고    scopus 로고
    • The FDA's Imprudent Caution
    • Miller, Henry I. 2010. The FDA's Imprudent Caution. Policy Review, no. 161: 73-85.
    • (2010) Policy Review, no. , vol.161 , pp. 73-85
    • Miller, H.I.1
  • 42
    • 77957268016 scopus 로고    scopus 로고
    • Promoting Agency Reputation through Public Advice: Advisory Committee Use in the FDA
    • Moffitt, Susan L. 2010. Promoting Agency Reputation through Public Advice: Advisory Committee Use in the FDA. Journal of Politics 72(3): 880-93.
    • (2010) Journal of Politics , vol.72 , Issue.3 , pp. 880-893
    • Moffitt, S.L.1
  • 46
    • 78650870921 scopus 로고    scopus 로고
    • Addressing the Citizenship and Democratic Deficits: The Potential of Deliberative Democracy for Public Administration
    • Nabatchi, Tina. 2010. Addressing the Citizenship and Democratic Deficits: The Potential of Deliberative Democracy for Public Administration. American Review of Public Administration 40(4): 376-99.
    • (2010) American Review of Public Administration , vol.40 , Issue.4 , pp. 376-399
    • Nabatchi, T.1
  • 47
    • 84862501648 scopus 로고    scopus 로고
    • Internet Use among Childhood and Young Adult Cancer Survivors Who Smoke: Implications for Cessation Interventions
    • Nagler, Rebekah H., Elaine Puleo, Kim Sprunck-Harrild, and Karen M. Emmons 2012. Internet Use among Childhood and Young Adult Cancer Survivors Who Smoke: Implications for Cessation Interventions. Cancer Causes and Control 23(4): 647-52.
    • (2012) Cancer Causes and Control , vol.23 , Issue.4 , pp. 647-652
    • Nagler, R.H.1    Puleo, E.2    Sprunck-Harrild, K.3    Emmons, K.M.4
  • 50
    • 84884356244 scopus 로고    scopus 로고
    • American Pain Foundation Shuts Down as Senators Launch Investigation of Prescription Narcotics. ProPublica: Journalism in the Public Interest, May 8. [accessed July 24, 2013].
    • Ornstein, Charles, and Tracy Weber 2012. American Pain Foundation Shuts Down as Senators Launch Investigation of Prescription Narcotics. ProPublica: Journalism in the Public Interest, May 8. http://www.propublica.org/article/senate-panel-investigates-drug-company-ties-to-pain-groups [accessed July 24, 2013].
    • (2012)
    • Ornstein, C.1    Weber, T.2
  • 51
    • 84857872033 scopus 로고    scopus 로고
    • Participatory Democracy Revisited: APSA Presidential Address
    • Pateman, Carole. 2012. Participatory Democracy Revisited: APSA Presidential Address. Perspectives on Politics 10(1): 7-19.
    • (2012) Perspectives on Politics , vol.10 , Issue.1 , pp. 7-19
    • Pateman, C.1
  • 52
    • 80053994977 scopus 로고    scopus 로고
    • Improving the Food and Drug Administration's Mandate to Ensure Postmarketing Drug Safety
    • Qato, Dima M., and G. Caleb Alexander 2011. Improving the Food and Drug Administration's Mandate to Ensure Postmarketing Drug Safety. Journal of the American Medical Association 306(14): 1595-96.
    • (2011) Journal of the American Medical Association , vol.306 , Issue.14 , pp. 1595-1596
    • Qato, D.M.1    Caleb Alexander, G.2
  • 53
    • 79960238308 scopus 로고    scopus 로고
    • Despite Criticism of the FDA Review Process, New Cancer Drugs Reach Patients Sooner in the United States than Europe
    • Roberts, Samantha A., Jeff D. Allen, and Ellen V. Sigal 2011. Despite Criticism of the FDA Review Process, New Cancer Drugs Reach Patients Sooner in the United States than Europe. Health Affairs 30(7): 1375-81.
    • (2011) Health Affairs , vol.30 , Issue.7 , pp. 1375-1381
    • Roberts, S.A.1    Allen, J.D.2    Sigal, E.V.3
  • 55
    • 79551595770 scopus 로고    scopus 로고
    • A Third Seat at the Table: An Insider's Perspective on Patient Representatives
    • Roth, Duane. 2011. A Third Seat at the Table: An Insider's Perspective on Patient Representatives. Hastings Center Report 41(1): 29-31.
    • (2011) Hastings Center Report , vol.41 , Issue.1 , pp. 29-31
    • Roth, D.1
  • 56
    • 79955666819 scopus 로고    scopus 로고
    • Health Advocacy Organizations and the Pharmaceutical Industry: An Analysis of Disclosure Practices
    • Rothman, Sheila M., Victoria H. Raveis, Anne Friedman, David J. Rothman 2011. Health Advocacy Organizations and the Pharmaceutical Industry: An Analysis of Disclosure Practices. American Journal of Public Health 101(4): 602-9.
    • (2011) American Journal of Public Health , vol.101 , Issue.4 , pp. 602-609
    • Rothman, S.M.1    Raveis, V.H.2    Friedman, A.3    Rothman, D.J.4
  • 57
    • 0002055580 scopus 로고    scopus 로고
    • The Women's Health Movement in the United States: From Grass-Roots Activism to Professional Agendas
    • Ruzek, Sheryl B., and Julie Becker 1999. The Women's Health Movement in the United States: From Grass-Roots Activism to Professional Agendas. Journal of the American Medical Women's Association 54(1): 4-8, 40.
    • (1999) Journal of the American Medical Women's Association , vol.54 , Issue.1
    • Ruzek, S.B.1    Becker, J.2
  • 59
    • 84864322520 scopus 로고    scopus 로고
    • Why and When Should We Use Public Deliberation?
    • Solomon, Stephanie, and Julia Abelson 2012. Why and When Should We Use Public Deliberation? Hastings Center Report 42(2): 17-19.
    • (2012) Hastings Center Report , vol.42 , Issue.2 , pp. 17-19
    • Solomon, S.1    Abelson, J.2
  • 60
    • 84859027610 scopus 로고    scopus 로고
    • Political Reasons, Deliberative Democracy, and Administrative Law
    • Staszewski, Glen. 2012. Political Reasons, Deliberative Democracy, and Administrative Law. Iowa Law Review 97(3): 849-912.
    • (2012) Iowa Law Review , vol.97 , Issue.3 , pp. 849-912
    • Staszewski, G.1
  • 63
    • 84884352592 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration (FDA). PDUFA Reauthorization Performance Goals and Procedures, Fiscal Years 2013 through 2017. [accessed July 24, 2013].
    • U.S. Food and Drug Administration (FDA). 2012a. PDUFA Reauthorization Performance Goals and Procedures, Fiscal Years 2013 through 2017. http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf. [accessed July 24, 2013].
    • (2012)
  • 64
    • 84884352548 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration (FDA). Patient Representatives to FDA Advisory Committees. [accessed July 24, 2013].
    • U.S. Food and Drug Administration (FDA). 2012b. Patient Representatives to FDA Advisory Committees. http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/PatientInvolvement/ucm123861.htm [accessed July 24, 2013].
    • (2012)
  • 65
    • 84884354254 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration (FDA). Prescription Drug User Fee Act. [accessed July 24, 2013].
    • U.S. Food and Drug Administration (FDA). 2013. Prescription Drug User Fee Act. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm272170.htm [accessed July 24, 2013].
    • (2013)
  • 69
    • 84884353689 scopus 로고    scopus 로고
    • FDA User Fee Renewal Addresses Drug Shortages, New Drug Development
    • Wechsler, Jill. 2012. FDA User Fee Renewal Addresses Drug Shortages, New Drug Development. Formulary 47: 125-26.
    • (2012) Formulary , vol.47 , pp. 125-126
    • Wechsler, J.1
  • 70
    • 0001277662 scopus 로고
    • The Study of Administration
    • Wilson, Woodrow. 1887. The Study of Administration. Political Science Quarterly 2(2): 197-222.
    • (1887) Political Science Quarterly , vol.2 , Issue.2 , pp. 197-222
    • Wilson, W.1
  • 71
  • 72
    • 84884356447 scopus 로고    scopus 로고
    • Social Media Offers New Recruitment Strategy for Clinical Trials. iHealthBeat: Reporting Technologies Impact on Health Care, March 1. [accessed July 24, 2013].
    • Zamosky, Lisa. 2012. Social Media Offers New Recruitment Strategy for Clinical Trials. iHealthBeat: Reporting Technologies Impact on Health Care, March 1. http://www.ihealthbeat.org/features/2012/social-media-offers-new-recruitment-strategy-for-clinical-trials.aspx [accessed July 24, 2013].
    • (2012)
    • Zamosky, L.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.