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 purposes.
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.
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