H.R. 4384 · 112th Congress
Patient Safety and Drug Labeling Improvement Act
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Never voted on. It didn't reach a floor vote before the 112th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
Van HollenSponsor1 cosponsor · 1 D
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Patient Safety and Drug Labeling Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to allow the holder of an approved abbreviated new drug application (generic drug approval) to change the labeling of a drug so approved in the same manner authorized by regulation for the holder of an approved new drug application.
What it does: CRS summary · Introduced in House · Apr 18, 2012
Patient Safety and Drug Labeling Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to allow the holder of an approved abbreviated new drug application (generic drug approval) to change the labeling of a drug so approved in the same manner authorized by regulation for the holder of an approved new drug application.
Allows conforming changes to be ordered to the labeling of the equivalent listed drug and each drug approved under the abbreviated new drug application process that corresponds to such listed drug.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Patient Safety and Drug Labeling Improvement Act
Latest action (Apr 20, 2012): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Apr 18, 2012
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.