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Volumn 29, Issue 16, 2011, Pages 2266-2272

Evaluation of oncology drugs at the European Medicines Agency and US Food and Drug Administration: When differences have an impact on clinical practice

Author keywords

[No Author keywords available]

Indexed keywords

ALEMTUZUMAB; ANTINEOPLASTIC AGENT; BORTEZOMIB; BUSULFAN; CETUXIMAB; ERLOTINIB; IMATINIB; IRINOTECAN; MELPHALAN; PEMETREXED; PLACEBO; PREDNISONE; SORAFENIB; TEMSIROLIMUS; TRASTUZUMAB;

EID: 79957965504     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2010.34.1248     Document Type: Article
Times cited : (62)

References (22)
  • 5
    • 84900630965 scopus 로고    scopus 로고
    • Australian Government, Department of Health and Ageing
    • Australian Government, Department of Health and Ageing: Sibutramine (Reductil) withdrawal in Australia. http://www.tga.gov.au/alerts/medicines/ reductilwithdrawal.htm
    • Sibutramine (Reductil) Withdrawal in Australia
  • 7
    • 79958259772 scopus 로고    scopus 로고
    • Directorate General of Health Services, Office of Drug Controller General of India: File No. 12-1/10-DC (Pt. 18). New Delhi, India, Office of Drug Controller General
    • Directorate General of Health Services, Office of Drug Controller General of India: Suspension of import/manufacture of rosiglitazone in the country. File No. 12-1/10-DC (Pt. 18). New Delhi, India, Office of Drug Controller General
    • Suspension of Import/manufacture of Rosiglitazone in the Country
  • 8
    • 77957952617 scopus 로고    scopus 로고
    • Regulatory action on rosiglitazone by the U.S. Food and Drug Administration
    • Woodcock J, Sharfstein JM, Hamburg M: Regulatory action on rosiglitazone by the U.S. Food and Drug Administration. N Engl J Med 363:1489-1491, 2010
    • (2010) N Engl J Med , vol.363 , pp. 1489-1491
    • Woodcock, J.1    Sharfstein, J.M.2    Hamburg, M.3
  • 9
    • 77957370174 scopus 로고    scopus 로고
    • Insiders criticise FDA's decision not to withdraw rosiglitazone
    • Cohen D: Insiders criticise FDA's decision not to withdraw rosiglitazone. BMJ 341:c5333, 2010
    • (2010) BMJ , vol.341
    • Cohen, D.1
  • 14
    • 0024467891 scopus 로고
    • The drug lag: An update of new drug introductions in the United States and in the United Kingdom, 1977 through 1987
    • Kaitin KI, Mattison N, Northington FK, et al: The drug lag: An update of new drug introductions in the United States and in the United Kingdom, 1977 through 1987. Clin Pharmacol Ther 46:121-138, 1989
    • (1989) Clin Pharmacol Ther , vol.46 , pp. 121-138
    • Kaitin, K.I.1    Mattison, N.2    Northington, F.K.3
  • 15
    • 75149190109 scopus 로고    scopus 로고
    • Therapeutic indications in oncology: Emerging features and regulatory dynamics
    • Tafuri G, Leufkens HG, Laing R, et al: Therapeutic indications in oncology: Emerging features and regulatory dynamics. Eur J Cancer 46:471-475, 2010
    • (2010) Eur J Cancer , vol.46 , pp. 471-475
    • Tafuri, G.1    Leufkens, H.G.2    Laing, R.3
  • 16
    • 79957950289 scopus 로고    scopus 로고
    • Homepage
    • European Medicines Agency: Homepage. http://www.ema.europa.eu
  • 17
    • 77955798710 scopus 로고    scopus 로고
    • US Food and Drug Administration: Drugs@FDA. http://www.accessdata.fda. gov/scripts/cder/drugsatfda/
    • Drugs@FDA
  • 18
    • 77953955207 scopus 로고    scopus 로고
    • Transparency at the Food and Drug Administration
    • Asamoah AK, Sharfstein JM: Transparency at the Food and Drug Administration. N Engl J Med 362:2341-2343, 2010
    • (2010) N Engl J Med , vol.362 , pp. 2341-2343
    • Asamoah, A.K.1    Sharfstein, J.M.2
  • 19
    • 77951045923 scopus 로고    scopus 로고
    • Europe's opportunity to open up drug regulation
    • Garattini S, Bertele' V: Europe's opportunity to open up drug regulation. BMJ 340:c1578, 2010
    • (2010) BMJ , vol.340
    • Garattini, S.1    Bertele, V.2
  • 20
    • 79957968974 scopus 로고    scopus 로고
    • Mundy A: Roche drug faces FDA curb. http://online.wsj.com/article/ SB10001424052748704073804576023512609387864.html?KEYWORDS= avastin#articleTabs%3Darticle
    • Roche Drug Faces FDA Curb
    • Mundy, A.1
  • 22
    • 34247463760 scopus 로고    scopus 로고
    • Paying for drug approvals: Who's using whom?
    • Avorn J: Paying for drug approvals: Who's using whom? N Engl J Med 356:1697-1700, 2007
    • (2007) N Engl J Med , vol.356 , pp. 1697-1700
    • Avorn, J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.