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Dentzer, S.1
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4
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84871943899
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[21] US Code, sec. 355(d)(5)
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[21] US Code, sec. 355(d)(5).
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5
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84871957395
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[21] US Code, sec. 355(d)
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[21] US Code, sec. 355(d).
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6
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84871989912
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[21] CFR, sec. 314.126
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[21] CFR, sec. 314.126.
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7
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84871949200
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[21] CFR, sec. 314.126(b)(2)
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[21] CFR, sec. 314.126(b)(2).
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8
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84871980621
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Note
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[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 ®].
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9
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0343456269
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Memorandumof understanding between Federal Trade Commission and the Food and Drug Administration
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Other device advertising is regulated by the Federal Trade Commission (FTC) (15 US Code sec. 52). Federal Trade Commission
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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.
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10
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[21] US Code, sec. 321(k)
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[21] US Code, sec. 321(k).
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11
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84871946450
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[21] US Code, sec. 321(m)
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[21] US Code, sec. 321(m).
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12
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84871941541
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United States, 335 U.S. 345
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Kordel v. United States, 335 U.S. 345 (1948).
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(1948)
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Kordel, V.1
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13
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84871946693
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[21] CFR, secs. 202.1(l), (2)
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[21] CFR, secs. 202.1(l), (2).
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14
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84871969499
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[21] CFR, secs. 314.50(c)(2), 601.2(a), and 814.20(b)(10)
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[21] CFR, secs. 314.50(c)(2), 601.2(a), and 814.20(b)(10).
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15
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84871992262
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[21] US Code, sec. 352(f)(1); 21 CFR, secs. 201.100(c)(1) and 801.109(c)
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[21] US Code, sec. 352(f)(1); 21 CFR, secs. 201.100(c)(1) and 801.109(c).
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16
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84871995581
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[21] US Code, secs. 502(n) and ®
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[21] US Code, secs. 502(n) and ®.
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17
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84871976197
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[21] CFR, sec. 202.1(l)(1)
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[21] CFR, sec. 202.1(l)(1).
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18
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84871957739
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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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[21] US Code, secs. 352(q)(1) and 321(n); 21 CFR, sec. 202.1(e)(5).
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19
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84871959499
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The Food and Drug Administration has the legal basis to restrict promotion of flawed comparative effectiveness research
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Academic detailing can play a key role in assessing and implementing comparative effectiveness research
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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.
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Avorn, J.2
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Reviewing hypothetical migraine studies using funding criteria from the Patient-Centered Outcomes Research Institute
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Selby J, Fleurence R, Lauer M, Schneeweiss S. Reviewing hypothetical migraine studies using funding criteria from the Patient-Centered Outcomes Research Institute. Health Aff (Millwood). 2012; 31(10):2193-99.
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