S 2620
REMEDY Act
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Bill overview
The Reforming Evergreening and Manipulation that Extends Drug Years Act (REMEDY Act) amends the Federal Food, Drug, and Cosmetic Act to address patent-related issues during the approval process for abbreviated new drug applications (ANDAs). Specifically, it clarifies that when a drug is approved after the bill’s enactment, the applicant must select a specific patent to be considered for the 30-month period granted to patent holders. This change aims to prevent pharmaceutical companies from strategically extending drug exclusivity by manipulating patents and ensures greater clarity and consistency in patent-related approvals.
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