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This bill amends the Federal Food, Drug, and Cosmetic Act to allow generic drugs to be approved even when their labeling omits safety information that is protected by patent or data exclusivity held by the brand-name drug manufacturer. The bill requires the FDA to approve such generic drugs promptly and to include any necessary safety information in the generic drug's labeling as determined by the FDA. The provision does not affect the scope or availability of patent or exclusivity protections themselves.
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