To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish a process to allow the holders of abbreviated new drug applications to make labeling changes to include new or updated safety-related information, and for other purposes.
Updated Drug Labeling for Patient Safety Act
This bill allows generic drug manufacturers to revise labels with updated safety information that differs from the referenced brand-name drug.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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