메뉴 건너뛰기




Volumn 31, Issue 10, 2012, Pages 2200-2205

The food and drug administration has the legal basis to restrict promotion of flawed comparative effectiveness research

Author keywords

[No Author keywords available]

Indexed keywords

PRESCRIPTION DRUG;

EID: 84871959499     PISSN: 02782715     EISSN: 15445208     Source Type: Journal    
DOI: 10.1377/hlthaff.2012.0787     Document Type: Article
Times cited : (9)

References (25)
  • 1
    • 84871977084 scopus 로고    scopus 로고
    • Communicating about comparative effectiveness research, a Health Affairs symposium on the issues
    • Dentzer S. Communicating about comparative effectiveness research: a Health Affairs symposium on the issues. Health Aff (Millwood). 2012;31(10):2183-87.
    • (2012) Health Aff (Millwood) , vol.31 , Issue.10 , pp. 2183-2187
    • Dentzer, S.1
  • 2
    • 79958036418 scopus 로고    scopus 로고
    • Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer
    • Kesselheim AS, Myers JA, Avorn J. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer. JAMA. 2011;305:2320-6.
    • (2011) JAMA , vol.305 , pp. 2320-2326
    • Kesselheim, A.S.1    Myers, J.A.2    Avorn, J.3
  • 3
    • 60349088130 scopus 로고    scopus 로고
    • FDAMA 1997 section 114, another look
    • Jackson JD. FDAMA 1997 section 114: another look. Value in Health. 2010;12:191-2.
    • (2010) Value in Health , vol.12 , pp. 191-192
    • Jackson, J.D.1
  • 4
    • 84871944831 scopus 로고    scopus 로고
    • CFR 202.1(e)(4)(ii)(c)
    • CFR 202.1(e)(4)(ii)(c).
  • 7
    • 84871969365 scopus 로고    scopus 로고
    • Silver Spring (MD) FDA; 9 [cited 28 Aug 2012]
    • Temple R. Communication of CER findings [Internet]. Silver Spring (MD): FDA; 2012 Feb 9 [cited 28 Aug 2012]. Available from: http:// www.npcnow.org/App_Themes/ Public/pdf/events/2012asymmetry/ rtemple_asym12.pdf
    • (2012) Communication of CER findings [Internet]
    • Temple, R.1
  • 8
    • 84871983524 scopus 로고    scopus 로고
    • Academic detailing can play a key role in assessing and implementing comparative effectiveness research
    • Fischer M, Avorn J. Academic detailing can play a key role in assessing and implementing comparative effectiveness research. Health Aff (Millwood). 2012;31 (10):2206-12.
    • (2012) Health Aff (Millwood) , vol.31 , Issue.10 , pp. 2206-2212
    • Fischer, M.1    Avorn, J.2
  • 9
    • 84871959238 scopus 로고    scopus 로고
    • Washington (DC) Department of Health and Human Services; 8 [cited 2012 Aug 28]
    • Panholzer L. RE: NDA #s 20-628, 21-785 (Invirase (saquinavir mesylate) capsules and tablets) [Internet]. Washington (DC): Department of Health and Human Services; 2010 Apr 8 [cited 2012 Aug 28]. Available from: http:// www.fda.gov/downloads/drugs/ guidancecomplianceregulatory information/enforcement activitiesbyfda/warningletters andnoticeofviolationlettersto pharmaceuticalcompanies/ ucm209517.pdf
    • (2010) RE, NDA s 20-628, 21-785 (Invirase (saquinavir mesylate) capsules and tablets) [Internet]
    • Panholzer, L.1
  • 10
    • 36549040492 scopus 로고    scopus 로고
    • In defense of pharmacoepidemiology-embracing the yin and yang of drug research
    • Avorn J. In defense of pharmacoepidemiology- embracing the yin and yang of drug research. N Engl J Med. 2007;357(22):2219-21.
    • (2007) N Engl J Med , vol.357 , Issue.22 , pp. 2219-2221
    • Avorn, J.1
  • 11
    • 0142157169 scopus 로고    scopus 로고
    • Evaluating medication effects outside of clinical trials, newuser designs
    • Ray WA. Evaluating medication effects outside of clinical trials: newuser designs. Am J Epidemiology. 2003;158(9):915-20.
    • (2003) Am J Epidemiology , vol.158 , Issue.9 , pp. 915-920
    • Ray, W.A.1
  • 12
    • 84864655722 scopus 로고    scopus 로고
    • Underreporting of cardiovascular events in the rofecoxib Alzheimer disease studies
    • Madigan D, Sigelman DW, Mayer JW, Furberg CD, Avorn J. Underreporting of cardiovascular events in the rofecoxib Alzheimer disease studies. Am Heart J. 2012;164(2): 186-93.
    • (2012) Am Heart J , vol.164 , Issue.2 , pp. 186-193
    • Madigan, D.1    Sigelman, D.W.2    Mayer, J.W.3    Furberg, C.D.4    Avorn, J.5
  • 13
    • 79955451265 scopus 로고    scopus 로고
    • Strategies and practices in offlabel marketing of pharmaceuticals, a retrospective analysis of whistleblower complaints
    • Kesselheim AS, Mello MM, Studdert DM. Strategies and practices in offlabel marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints. PLoS Med. 2011; 8(4):e1000431.
    • (2011) PLoS Med , vol.8 , Issue.4 , pp. 1000431
    • Kesselheim, A.S.1    Mello, M.M.2    Studdert, D.M.3
  • 15
    • 84858645799 scopus 로고    scopus 로고
    • Prospective observational studies to assess comparative effectiveness, the ISPOR good research practices task force report
    • Berger ML, Dreyer N, Anderson F, Towse A, Sedrakyan A, Normand SL. Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report. Value in Health. 2012;15(2):217-30.
    • (2012) Value in Health , vol.15 , Issue.2 , pp. 217-230
    • Berger, M.L.1    Dreyer, N.2    Anderson, F.3    Towse, A.4    Sedrakyan, A.5    Normand, S.L.6
  • 16
    • 84871946996 scopus 로고    scopus 로고
    • International Society of Pharmacoepidemiology. Bethesda (MD), ISPE
    • International Society of Pharmacoepidemiology. GRACE principles: good research for comparative effectiveness [Internet]. Bethesda (MD): ISPE; 2010 Apr 10 [cited 2012 Aug 28]. Available from: http:// www.pharmacoepi.org/resources/ GRACE_Principles.pdf
    • (2010) GRACE., principles, good research for comparative effectiveness, [Internet]
  • 17
    • 84863556829 scopus 로고    scopus 로고
    • Increasing scientific standards independence, and transparency in post-authorisation studies, the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
    • Blake KV, Devries CS, Arlett P, Kurz X, Fitt H. Increasing scientific standards, independence, and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Pharmacoepidemiol Drug Saf. 2012;21(7): 690-6.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , Issue.7 , pp. 690-696
    • Blake, K.V.1    Devries, C.S.2    Arlett, P.3    Kurz, X.4    Fitt, H.5
  • 18
    • 79951597867 scopus 로고    scopus 로고
    • Postmarketing studies of drug safety
    • Schneeweiss S, Avorn J. Postmarketing studies of drug safety. BMJ. 2011;342:d342.
    • (2011) BMJ , vol.342
    • Schneeweiss, S.1    Avorn, J.2
  • 20
    • 77956534338 scopus 로고    scopus 로고
    • Comparative effectiveness research, the view from a pharmaceutical company
    • Berger ML, Grainger D. Comparative effectiveness research: the view from a pharmaceutical company. Pharmacoeconomics. 2010;28(10): 915-22.
    • (2010) Pharmacoeconomics , vol.28 , Issue.10 , pp. 915-922
    • Berger, M.L.1    Grainger, D.2
  • 21
    • 67651042983 scopus 로고    scopus 로고
    • High-dimensional propensity score adjustment in studies of treatment effects using health care claims data
    • Schneeweiss S, Rassen JA, Glynn RJ, Avorn J, Mogun H, Brookhart MA. High-dimensional propensity score adjustment in studies of treatment effects using health care claims data. Epidemiology. 2009;20(4):512-22.
    • (2009) Epidemiology , vol.20 , Issue.4 , pp. 512-522
    • Schneeweiss, S.1    Rassen, J.A.2    Glynn, R.J.3    Avorn, J.4    Mogun, H.5    Brookhart, M.A.6
  • 23
    • 84871965934 scopus 로고    scopus 로고
    • Citizens United v. Federal Election Commission, 558 U.S. 50
    • Citizens United v. Federal Election Commission, 558 U.S. 50 (2010).
    • (2010)
  • 24
    • 80051854118 scopus 로고    scopus 로고
    • Off-label prescription advertising the Food and Drug Administration, and the First Amendment, a study in the values of commercial speech protection
    • Klasmeier C, Redish MH. Off-label prescription advertising, the Food and Drug Administration, and the First Amendment: a study in the values of commercial speech protection. Am J Law Med. 2011; 37(2-3):315-57.
    • (2011) Am J Law Med , vol.37 , Issue.2-3 , pp. 315-357
    • Klasmeier, C.1    Redish, M.H.2
  • 25
    • 42249097132 scopus 로고    scopus 로고
    • Pharmaceutical promotion to physicians and First Amendment rights
    • Kesselheim AS, Avorn J. Pharmaceutical promotion to physicians and First Amendment rights. N Engl J Med. 2008;358:1727-32.
    • (2008) N Engl J Med , vol.358 , pp. 1727-1732
    • Kesselheim, A.S.1    Avorn, J.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.