Sec. 305. Improving FDA–CMS communication regarding transformative new therapies
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/bill/117/hr/6000/ih/section-305·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Upon the designation of a product as a breakthrough therapy, a fast track product, or a product eligible for accelerated approval under subsection (a), (b), or (c), respectively, of section 506 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 ), the Commissioner of Food and Drugs and the Administrator of the Centers for Medicare & Medicaid Services shall— maintain communication with each other regarding approval and coverage decisions with respect to such product; and share such information with each other as may be appropriate to inform and coordinate such decisions.
In approving or designating a product described in subsection (a), the Commissioner of Food and Drugs and the Administrator of the Centers for Medicare & Medicaid Services shall ensure that the process for approval or designation remains separate and distinct.
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Sec. 305
Improving FDA–CMS communication regarding transformative new therapies
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