date of approval

(2) Date of approval For purposes of this section, with respect to an application described in paragraph (1), the term “date of approval” shall mean the later of— (A) the date an application under subsection (b) is approved under subsection (c); or (B) the date of issuance of the interim final rule controlling the drug.


21 USC § 360b(q)(2)

Scoping language

For purposes of this section
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