S.2295 - Patient Safety and Generic Labeling Improvement Act112th Congress (2011-2012)
Summary: S.2295 — 112th Congress (2011-2012)
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.