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;


21 USC § 360b(d)(3)

Scoping language

As used in this section
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