S.2295 - Patient Safety and Generic Labeling Improvement Act112th Congress (2011-2012)
|Sponsor:||Sen. Leahy, Patrick J. [D-VT] (Introduced 04/18/2012)|
|Committees:||Senate - Health, Education, Labor, and Pensions|
|Latest Action:||04/18/2012 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2498) (All Actions)|
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Summary: S.2295 — 112th Congress (2011-2012)All Bill Information (Except Text)
Introduced in Senate (04/18/2012)
Patient Safety and Generic 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.