Sec. 302. REMS approval process for subsequent filers
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Section 505–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 ) is amended— in subsection (g)(4)(B)— in clause
(i)by striking or after the semicolon; in clause
(ii)by striking the period at the end and inserting ; or ; and by adding at the end the following: accommodate different approved risk evaluation and mitigation strategies for a reference drug product and a drug that is the subject of an abbreviated new drug application. ; and in subsection (i)(1), by striking subparagraph
(B)and inserting the following: Elements to assure safe use, if required under subsection
(f)for the listed drug in accordance with the following: Subject to clause (ii), a drug that is the subject of an abbreviated new drug application may use— a single, shared system with the listed drug under subsection (f); or a different, comparable aspect of the elements to assure safe use under subsection (f). The Secretary may require a drug that is the subject of an abbreviated new drug application and the listed drug to use a single, shared system under subsection (f), if the Secretary determines that no different, comparable aspect of the elements to assure safe use could satisfy the requirements of subsection (f). .
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Sec. 302
REMS approval process for subsequent filers
Cite21 USC 355–1
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