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 ), as amended by section 301, is further 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, comparable aspects of the elements to assure safe use for a drug that is the subject of an application under section 505(j), and the applicable listed drug. ; in subsection (i)(1), by striking subparagraph

(C)and inserting the following: Elements to assure safe use, if required under subsection

(f)for the listed drug, which, subject to clause (ii), for a drug that is the subject of an application under section 505(j) 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 application under section 505(j) 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). ; in subsection (i), by adding at the end the following: If the Secretary approves, in accordance with paragraph (1)(C)(i)(II), a different, comparable aspect of the elements to assure safe use under subsection

(f)for a drug that is the subject of an abbreviated new drug application under section 505(j), the Secretary may require that such different comparable aspect of the elements to assure safe use can be used with respect to any other drug that is the subject of an application under section 505(j) or 505(b) that references the same listed drug. ; and by adding at the end the following: When used in this section, the terms different, comparable aspect of the elements to assure safe use or different, comparable approved risk evaluation and mitigation strategies means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section 505(j) that uses different methods or operational means than the strategy required under subsection

(a)for the applicable listed drug, or other application under section 505(j) with the same such listed drug, but achieves the same level of safety as such strategy. .

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21 USC 355–1

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Sec. 302

REMS approval process for subsequent filers

Cite21 USC 355–1

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