substantial evidence

(3) As used in this section, the term “substantial evidence” means evidence consisting of one or more adequate and well controlled investigations, such as— (A) a study in a target species; (B) a study in laboratory animals; (C) any field investigation that may be required under this section and that meets the requirements of subsection (b)(3) if a presubmission conference is requested by the applicant; (D) a bioequivalence study; or (E) an in vitro study; by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.


21 USC § 360b(d)(3)

Scoping language

As used in this section
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