Reforming Evergreening and Manipulation that Extends Drug Years Act or REMEDY Act amends the Federal Food, Drug, and Cosmetic Act.
The Reforming Evergreening and Manipulation that Extends Drug Years Act or the REMEDY Act amends the Federal Food, Drug, and Cosmetic Act. The bill makes changes to the approval provisions for abbreviated new drug applications (ANDAs). It specifies that when a holder of an approved application first files information about one or more patents, they must select one patent for which the owner or licensee may be eligible for a 30-month period. The selection of this patent cannot be changed or amended.
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- Legal Framework
- Critical Issues
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