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Volumn 338, Issue 7704, 2009, Pages 1157-

Does the FDA have the authority to trump the Declaration of Helsinki?

Author keywords

[No Author keywords available]

Indexed keywords

EDITORIAL; FOOD AND DRUG ADMINISTRATION; GOOD CLINICAL PRACTICE; MEDICAL ETHICS; MEDICAL RESEARCH; MEDICAL SOCIETY; PRIORITY JOURNAL; QUALITY CONTROL; UNITED STATES;

EID: 67650045408     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.b1559     Document Type: Editorial
Times cited : (26)

References (13)
  • 1
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    • 21 CFR part 312. Human subject protection; foreign clinical studies not conducted under an investigational new drug application
    • and, 28 April, effective, October 27
    • DHHS Food and Drug Administration. 21 CFR part 312. Human subject protection; foreign clinical studies not conducted under an investigational new drug application. Final rule 28 April 2008, effective, October 27 2008., www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o= 0900006480537f08.
    • (2008) Final rule
    • Food, D.H.H.S.1
  • 2
    • 15744371179 scopus 로고    scopus 로고
    • US exceptionalism comes to research ethics
    • CrossRef][Web of Science][Medline
    • Lurie P, Greco DB. US exceptionalism comes to research ethics. Lancet 2005;365:1117-9. [CrossRef][Web of Science][Medline]
    • (2005) Lancet , vol.365 , pp. 1117-1119
    • Lurie, P.1    Greco, D.B.2
  • 3
    • 84882245985 scopus 로고    scopus 로고
    • Trials on trial: the Food and Drug Administration should rethink its rejection of the Declaration of Helsinki [editorial]. Nature 2008;453:427-8.[Medline]
    • Trials on trial: the Food and Drug Administration should rethink its rejection of the Declaration of Helsinki [editorial]. Nature 2008;453:427-8.[Medline]
  • 4
    • 54949105799 scopus 로고    scopus 로고
    • Normile D. Ethics. Clinical trials guidelines at odds with US policy. Science 2008;322:516. [Abstract/Free Full Text]
    • Normile D. Ethics. Clinical trials guidelines at odds with US policy. Science 2008;322:516. [Abstract/Free Full Text]
  • 5
    • 35148823242 scopus 로고    scopus 로고
    • Goodyear MD, Krleza-Jeric K, Lemmens T. The Declaration of Helsinki. BMJ 2007;335:624-5.[Free Full Text]
    • Goodyear MD, Krleza-Jeric K, Lemmens T. The Declaration of Helsinki. BMJ 2007;335:624-5.[Free Full Text]
  • 7
    • 58049151944 scopus 로고    scopus 로고
    • Helsinki discords: FDA, ethics, and international drug trials
    • CrossRef][Web of Science][Medline
    • Kimmelman J, Weijer C, Meslin EM. Helsinki discords: FDA, ethics, and international drug trials. Lancet 2009;373:13-4.[CrossRef][Web of Science][Medline]
    • (2009) Lancet , vol.373 , pp. 13-14
    • Kimmelman, J.1    Weijer, C.2    Meslin, E.M.3
  • 8
    • 55249097892 scopus 로고    scopus 로고
    • Moral imperialism and multi-centric clinical trials in peripheral countries
    • Web of Science][Medline
    • Garrafa V, Lorenzo C. Moral imperialism and multi-centric clinical trials in peripheral countries. Cad Saude Publica 2008;24:2219-26.[Web of Science][Medline]
    • (2008) Cad Saude Publica , vol.24 , pp. 2219-2226
    • Garrafa, V.1    Lorenzo, C.2
  • 10
    • 3442881628 scopus 로고    scopus 로고
    • CIOMS' placebo rule and the promotion of negligent medical practice
    • CrossRef][Medline
    • Lemmens T, Sprumont D, Nys H, Singh J, Glass KC. CIOMS' placebo rule and the promotion of negligent medical practice. Eur J Health Law 2004;11:153-74.[CrossRef][Medline]
    • (2004) Eur J Health Law , vol.11 , pp. 153-174
    • Lemmens, T.1    Sprumont, D.2    Nys, H.3    Singh, J.4    Glass, K.C.5
  • 11
    • 0004177252 scopus 로고    scopus 로고
    • World Medical Association. Declaration of Helsinki. 2008. www.wma.net/e/policy/pdf/17c.pdf.
    • (2008) Declaration of Helsinki
  • 12
    • 55449107480 scopus 로고    scopus 로고
    • Goodyear MD, Eckenwiler LA, Ells C. Fresh thinking about the Declaration of Helsinki. BMJ 2008;337:a2128.[Free Full Text]
    • Goodyear MD, Eckenwiler LA, Ells C. Fresh thinking about the Declaration of Helsinki. BMJ 2008;337:a2128.[Free Full Text]
  • 13
    • 84882274697 scopus 로고    scopus 로고
    • Abdullahi v Pfizer. US Court of Appeals 2d Cir. 2009 US App LEXIS 1768, 30 Jan 2009.
    • Abdullahi v Pfizer. US Court of Appeals 2d Cir. 2009 US App LEXIS 1768, 30 Jan 2009.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.