H.R.3230 - Keeping America Competitive Through Harmonization Act of 2011

To direct the Food and Drug Administration, with respect to devices, to enter into agreements with certain countries regarding methods and approaches to harmonizing certain regulatory requirements. view all titles (2)

All Bill Titles

  • Official: To direct the Food and Drug Administration, with respect to devices, to enter into agreements with certain countries regarding methods and approaches to harmonizing certain regulatory requirements. as introduced.
  • Short: Keeping America Competitive Through Harmonization Act of 2011 as introduced.

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Introduced
 
House
Passes
 
Senate
Passes
 
President
Signs
 

 
10/14/11
 
 
 
 
 
 
 

Official Summary

Keeping America Competitive Through Harmonization Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to enter into agreements with listed countries (countries eligible for exports of drugs or biological products that hav

Official Summary

Keeping America Competitive Through Harmonization Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to enter into agreements with listed countries (countries eligible for exports of drugs or biological products that have not been approved under certain circumstances) regarding methods and approaches to harmonizing regulatory requirements for premarket review, inspections, and common international labeling symbols. Requires the Secretary to report on the agreements entered under this Act and to itemize the methods and approaches that have been harmonized pursuant to this Act.

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