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H.R. 4384

BillFederalHouseIn Committee
Patient Safety and Drug Labeling Improvement Act
About This Bill
Committee
Latest Action · April 20, 2012
Referred to the Subcommittee on Health.
Congress
112th (2011–2013)
Introduced
April 18, 2012
Sponsor
Rep. Chris Van HollenD
Cosponsors (1)
1D 0R
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Summary

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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.

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