Slides (Updated 9/13/13)
Slides (Updated 9/13/13)
Slides (Updated 9/13/13)
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Presenting Data: Legal Authorities (cont.)<br />
§ 21 CFR 202.1(e)(7) – advertising regulation providing an ad “may”<br />
lack fair balance where:<br />
§ Contains favorable information or conclusions from a study that is<br />
inadequate in design, scope, or conduct to furnish significant support for<br />
such information or conclusions<br />
§ Uses statistical analyses and techniques on a retrospective basis to discover<br />
and cite findings not soundly supported by the study, or to suggest<br />
scientific validity and rigor for data from studies the design or protocol of<br />
which are not amenable to formal statistical evaluations<br />
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