HR 4384
112th Congress
House
Health
Consumer affairs
Drug safety, medical device, and laboratory regulation
Health information and medical records
Prescription drugs
Patient Safety and Drug Labeling Improvement Act
Introduced: April 18, 2012
Introduced by:
Van Hollen, Chris
Democratic
· Maryland
See on congress.gov
Everywhere this bill has been
3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 20, 2012
Referred to the Subcommittee on Health.
Apr 18, 2012
Referred to the House Committee on Energy and Commerce.
Apr 18, 2012
Introduced in House
Plain-English summary
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.
What's happening now
Referred to the Subcommittee on Health.
Committees of jurisdiction
2