United States · Bill · S
S. 2295 (112th)
Patient Safety and Generic Labeling Improvement Act
Introduced
18 April 2012
Last action
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Status
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2498)
Sponsors
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Subjects
Discovery layer
Source updated
14 August 2025
Summary
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.
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Documents
3 official files
Introduced in Senate (text)
Introduced in Senate · EN · 18 April 2012
Introduced in Senate (PDF)
Introduced in Senate · EN · 18 April 2012
Introduced in Senate
summary · EN · 18 April 2012
Sponsors
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Sources
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- Official source: https://www.congress.gov/bill/112th-congress/senate-bill/2295
- Open data entity: https://api.congress.gov/v3/bill/112/s/2295