qualified safety and effectiveness testing

(2) For purposes of paragraph (1) of this section— (A) The term “qualified safety and effectiveness testing” means testing— (i) which occurs after the date such new animal drug is designated under this section and before the date on which an application with respect to such drug is submitted under section 360b of this title ; and (ii) which is carried out under an investigational exemption under section 360b(j) of this title . (B) The term “manufacturing expenses” means expenses incurred in developing processes and procedures associated with manufacture of the designated new animal drug which occur after the new animal drug is designated under this section and before the date on which an application with respect to such new animal drug is submitted under section 360b or 360ccc of this title .

Source

21 USC § 360ccc-2(b)(2)


Scoping language

None identified, default scope is assumed to be the parent (part F) of this section.
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