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Volumn 31, Issue 10, 2012, Pages 2188-2192

Regulatory requirements of the food and drug administration would preclude product claims based on observational research

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONSENSUS; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH PROMOTION; HUMAN; MEDICAL RESEARCH; METHODOLOGY; OBSERVATIONAL STUDY; PRESCRIPTION; PUBLIC HEALTH; SCIENCE;

EID: 84871966670     PISSN: 02782715     EISSN: 15445208     Source Type: Journal    
DOI: 10.1377/hlthaff.2012.0958     Document Type: Article
Times cited : (5)

References (21)
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    • Dentzer S Communicating about comparative effectiveness research: a Health Affairs symposium on the issues. Health Aff (Millwood). 2012;31(10), 2183-87.
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    • Dentzer, S.1
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    • [21] US Code, sec. 355(d)(5)
    • [21] US Code, sec. 355(d)(5).
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    • [21] US Code, sec. 355(d)
    • [21] US Code, sec. 355(d).
  • 6
    • 84871989912 scopus 로고    scopus 로고
    • [21] CFR, sec. 314.126
    • [21] CFR, sec. 314.126.
  • 7
    • 84871949200 scopus 로고    scopus 로고
    • [21] CFR, sec. 314.126(b)(2)
    • [21] CFR, sec. 314.126(b)(2).
  • 8
    • 84871980621 scopus 로고    scopus 로고
    • Note
    • [21] US Code, secs. 502(a), (n), (q), and ®. The FDA has authority over labeling and advertising for prescription drugs intended for human use [secs. 352(a) and (n)]. The FDA also has authority over labeling for all devices [sec. 352(a)]. The agency's authority over device advertising extends to restricted devices [secs. 352(q) and ®].
  • 9
    • 0343456269 scopus 로고
    • Memorandumof understanding between Federal Trade Commission and the Food and Drug Administration
    • Other device advertising is regulated by the Federal Trade Commission (FTC) (15 US Code sec. 52). Federal Trade Commission
    • Other device advertising is regulated by the Federal Trade Commission (FTC) (15 US Code, sec. 52). Federal Trade Commission. Memorandumof understanding between Federal Trade Commission and the Food and Drug Administration. Fed Regist. 1971;36(180), 18539.
    • (1971) Fed Regist , vol.36 , Issue.180 , pp. 18539
  • 10
    • 84871961087 scopus 로고    scopus 로고
    • [21] US Code, sec. 321(k)
    • [21] US Code, sec. 321(k).
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    • 84871946450 scopus 로고    scopus 로고
    • [21] US Code, sec. 321(m)
    • [21] US Code, sec. 321(m).
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    • 84871941541 scopus 로고
    • United States, 335 U.S. 345
    • Kordel v. United States, 335 U.S. 345 (1948).
    • (1948)
    • Kordel, V.1
  • 13
    • 84871946693 scopus 로고    scopus 로고
    • [21] CFR, secs. 202.1(l), (2)
    • [21] CFR, secs. 202.1(l), (2).
  • 14
    • 84871969499 scopus 로고    scopus 로고
    • [21] CFR, secs. 314.50(c)(2), 601.2(a), and 814.20(b)(10)
    • [21] CFR, secs. 314.50(c)(2), 601.2(a), and 814.20(b)(10).
  • 15
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    • [21] US Code, secs. 502(n) and ®
    • [21] US Code, secs. 502(n) and ®.
  • 17
    • 84871976197 scopus 로고    scopus 로고
    • [21] CFR, sec. 202.1(l)(1)
    • [21] CFR, sec. 202.1(l)(1).
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    • [21] US Code, secs. 352(q)(1) and 321(n); 21 CFR, sec. 202.1(e)(5)
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    • 84871959499 scopus 로고    scopus 로고
    • The Food and Drug Administration has the legal basis to restrict promotion of flawed comparative effectiveness research
    • Kesselheim A, Avorn J. The Food and Drug Administration has the legal basis to restrict promotion of flawed comparative effectiveness research. Health Aff (Millwood). 2012;31 (10):2200-05.
    • (2012) Health Aff (Millwood) , vol.31 , Issue.10 , pp. 2200-2205
    • Kesselheim, A.1    Avorn, J.2
  • 20
    • 84871983524 scopus 로고    scopus 로고
    • Academic detailing can play a key role in assessing and implementing comparative effectiveness research
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  • 21
    • 84871999180 scopus 로고    scopus 로고
    • Reviewing hypothetical migraine studies using funding criteria from the Patient-Centered Outcomes Research Institute
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    • (2012) Health Aff (Millwood) , vol.31 , Issue.10 , pp. 2193-2199
    • Selby, J.1    Fleurence, R.2    Lauer, M.3    Schneeweiss, S.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.