A bill to permit manufacturers of generic drugs to provide additional warnings with respect to such drugs in the same manner that the Food and Drug Administration allows brand names to do so.
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.
Referred to the Subcommittee on Health.
Introduced in Senate
Sponsor introductory remarks on measure. (CR S2497-2498, S2499-2500)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2498)
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