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.
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.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
checking server…
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line