Sec. 404. Change conditions of first generic exclusivity to spur access and competition
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/bill/117/hr/5237/ih/section-404A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Clause
(iv)of section 505(j)(5)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(B) ) is amended— in subclause (I), after 180 days after the date of the first commercial marketing of the drug (including the commercial marketing of the listed drug) by any first applicant by inserting or by an applicant whose application is approved pursuant to subclause
(III); and by adding at the end the following new subclause: An application containing a certification described in paragraph (2)(A)(vii)(IV) that is for a drug for which a first applicant has submitted an application containing such a certification can be approved notwithstanding the eligibility of a first applicant for the 180-day exclusivity period described in subclause (II)(aa) if each of the following conditions is met: The approval of such an application could be made effective, but for the eligibility of a first applicant for 180-day exclusivity under this clause. At least 30 months have passed since the date of submission of an application for the drug by at least one first applicant. Approval of an application for the drug submitted by at least one first applicant is not precluded under clause
(iii). No application for the drug submitted by any first applicant is approved at the time the conditions under items (aa), (bb), and
(cc)are all met, regardless of whether such an application is subsequently approved. .
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Sec. 404
Change conditions of first generic exclusivity to spur access and competition
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