H.R.4384 - Patient Safety and Drug Labeling Improvement Act

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. view all titles (2)

All Bill Titles

  • Official: 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. as introduced.
  • Short: Patient Safety and Drug Labeling Improvement Act as introduced.

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Introduced
 
House
Passes
 
Senate
Passes
 
President
Signs
 

 
04/18/12
 
 
 
 
 
 
 

Official 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 hol

Official 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.

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Organizations Supporting H.R.4384

  • Alliance for Justice
  • American Association for Justice
  • American Association of Retired Persons
  • Baum, Hedlund, Aristei & Goldman, PC
  • Consumer Action
  • Consumer Federation of America
  • ...and 5 more. See all.

Organizations Opposing H.R.4384

  • Generic Pharmaceutical Association


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