qualified safety and effectiveness testing

(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 undersection 360b of this title; and (ii)which is carried out under an investigational exemption undersection 360b(j) of this title.


21 USC § 360ccc-2(b)(2)(A)

Scoping language

For purposes of paragraph
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