Senate bill S4351-117

Health, Education, Labor, and Pensions Committee

A bill to amend the Federal Food, Drug, and Cosmetic Act to clarify the conditions under which the Secretary of Health and Human Services can approve generic drug applications with labeling temporarily different than the brand name drug, and for other pur

• Last activity on Jun 06, 2022

• Introduced Jun 06, 2022

• By Sen. Romney, Mitt [R-UT]

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Main Subject: Health

Enhanced Access to Affordable Medicines Act of 2022

This bill specifies that the Food and Drug Administration may approve generic drugs with different labels than the brand-name versions if, among other requirements, a revised label for the brand-name drug is approved within 90 days of when the generic is otherwise eligible for approval.

HR6973-117, HR7667-117,

Senate Actions

IntroReferral
Jun. 06 2022	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Library of Congress Actions

IntroReferral
Jun. 06 2022	Introduced in Senate

Senate bill S4351-117

A bill to amend the Federal Food, Drug, and Cosmetic Act to clarify the conditions under which the Secretary of Health and Human Services can approve generic drug applications with labeling temporarily different than the brand name drug, and for other pur

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