Sec. 608. Pediatric information added to labeling
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/bill/115/hr/2430/eh/section-608A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 505A(o) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355a(o) ) is amended— in the subsection heading, by striking ; Under Section 505
(j)in paragraph (1)— by striking under section 505(j) and inserting under subsection (b)(2) or
(j)of section 505 ; and by striking or by exclusivity under clause
(iii)or
(iv)of section 505(j)(5)(F) and inserting , or by exclusivity under clause
(iii)or
(iv)of section 505(j)(5)(F), clause
(iii)or
(iv)of section 505(c)(3)(E), or section 527(a), or by an extension of such exclusivity under this section or section 505E ; in paragraph (2), in the matter preceding subparagraph (A)— by inserting clauses
(iii)and
(iv)of section 505(c)(3)(E), or section 527, after section 505(j)(5)(F), ; and by striking drug approved under section 505(j) and inserting drug approved pursuant to an application submitted under subsection (b)(2) or
(j)of section 505 ; and by amending paragraph
(3)to read as follows: This subsection does not affect— the availability or scope of exclusivity under— this section; section 505 for pediatric formulations; or section 527; the availability or scope of an extension to any such exclusivity, including an extension under this section or section 505E; the question of the eligibility for approval under section 505 of any application described in subsection (b)(2) or
(j)of such section that omits any other aspect of labeling protected by exclusivity under— clause
(iii)or
(iv)of section 505(j)(5)(F); clause
(iii)or
(iv)of section 505(c)(3)(E); or section 527(a); or except as expressly provided in paragraphs
(1)and (2), the operation of section 505 or section 527. .
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Sec. 608
Pediatric information added to labeling
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