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Volumn 303, Issue 10, 2010, Pages 979-980

Building comparative efficacy and tolerability into the FDA approval process

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; ANTICOAGULANT AGENT; ANTIINFECTIVE AGENT;

EID: 77949323966     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2010.257     Document Type: Note
Times cited : (41)

References (9)
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    • US Food and Drug Administration. About FDA: what we do. http://www.fda .gov/AboutFDA/WhatWeDo/default.htm. Accessed February 2, 2010.
    • About FDA: What we do
    • Food, U.S.1
  • 2
    • 73949084847 scopus 로고    scopus 로고
    • Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices
    • Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA. 2009;302(24): 2679-2685.
    • (2009) JAMA , vol.302 , Issue.24 , pp. 2679-2685
    • Dhruva, S.S.1    Bero, L.A.2    Redberg, R.F.3
  • 3
    • 77949393892 scopus 로고    scopus 로고
    • Code of Federal Regulations. Title 21, part 314-Applications for FDA approval to market a new drug: subpart D-FDA action on applications and abbreviated applications. Section 314.125-Refusal to approve an application, February 2, 2010
    • Code of Federal Regulations. Title 21, part 314-Applications for FDA approval to market a new drug: subpart D-FDA action on applications and abbreviated applications. Section 314.125-Refusal to approve an application. http: //www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314 .125. Accessed February 2, 2010.
  • 4
    • 77949419212 scopus 로고    scopus 로고
    • Code of Federal Regulations. Title 21, part 860-Medical device classification procedures: subpart A-general. Section 860.7-Determination of safety and effectiveness, February 2, 2010
    • Code of Federal Regulations. Title 21, part 860-Medical device classification procedures: subpart A-general. Section 860.7-Determination of safety and effectiveness. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfcfr/CFRSearch .cfm?fr=860.7. Accessed February 2, 2010.
  • 5
    • 74049109695 scopus 로고    scopus 로고
    • Industry influence on comparative-effectiveness research funded through health care reform
    • Selker HP, Wood AJJ. Industry influence on comparative-effectiveness research funded through health care reform. N Engl J Med. 2009;361(27):2595-2597.
    • (2009) N Engl J Med , vol.361 , Issue.27 , pp. 2595-2597
    • Selker, H.P.1    Wood, A.J.J.2
  • 6
    • 67649226035 scopus 로고    scopus 로고
    • Does comparative effectiveness have a comparative edge?
    • Alexander GC, Stafford RS. Does comparative effectiveness have a comparative edge? JAMA. 2009;301(23):2488-2490.
    • (2009) JAMA , vol.301 , Issue.23 , pp. 2488-2490
    • Alexander, G.C.1    Stafford, R.S.2
  • 7
    • 70349472886 scopus 로고    scopus 로고
    • New, but not improved? incorporating comparative-effectiveness information into FDA labeling
    • Stafford RS, Wagner TH, Lavori PW. New, but not improved? incorporating comparative-effectiveness information into FDA labeling. N Engl J Med. 2009; 361(13):1230-1233.
    • (2009) N Engl J Med , vol.361 , Issue.13 , pp. 1230-1233
    • Stafford, R.S.1    Wagner, T.H.2    Lavori, P.W.3
  • 8
    • 0036742342 scopus 로고    scopus 로고
    • Design and reporting modifications in industry-sponsored comparative psychopharmacology trials
    • Safer DJ. Design and reporting modifications in industry-sponsored comparative psychopharmacology trials. J Nerv Ment Dis. 2002;190(9):583-592.
    • (2002) J Nerv Ment Dis , vol.190 , Issue.9 , pp. 583-592
    • Safer, D.J.1
  • 9
    • 77949383011 scopus 로고    scopus 로고
    • European Medicines Agency. EU standard of medicinal product registration: clinical evaluation of risk/benefit-the role of comparator studies. http://www .emea.europa.eu/pdfs/human/press/pos/11931904en.pdf. Posted October 2004. Accessed February 2, 2010.
    • European Medicines Agency. EU standard of medicinal product registration: clinical evaluation of risk/benefit-the role of comparator studies. http://www .emea.europa.eu/pdfs/human/press/pos/11931904en.pdf. Posted October 2004. Accessed February 2, 2010.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.