§355g. Utilizing real world evidence — Inbound Citations

Citations to §355g(b)

• 21 U.S.C. § 355h(r)(1)(A)

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  (A) in evaluating the generally recognized as safe and effective status of active ingredients used in nonprescription drugs intended for topical administration for purposes of subsection (a), utilize standards that allow for the use of real world evidence (as defined in section 355g(b) of this title), as appropriate, as part of a comprehensive evaluation of scientific evidence to demonstrate the safety and effectiveness of such active ingredients, to supplement evidence from traditional clinical trials, provided that such standards allow the Secretary to evaluate whether the benefits of such active ingredients outweigh the risks; and