H.R.4332 - Generic Drug Application Review Fairness Act of 2012

To amend section 505(j) of the Federal Food, Drug, and Cosmetic Act to extend the period for a first applicant, with respect to a generic drug, to obtain tentative approval without forfeiting the 180-day exclusivity period, and for other purposes. view all titles (2)

All Bill Titles

  • Official: To amend section 505(j) of the Federal Food, Drug, and Cosmetic Act to extend the period for a first applicant, with respect to a generic drug, to obtain tentative approval without forfeiting the 180-day exclusivity period, and for other purposes. as introduced.
  • Short: Generic Drug Application Review Fairness Act of 2012 as introduced.

This Bill currently has no wiki content. If you would like to create a wiki entry for this bill, please Login, and then select the wiki tab to create it.

Bill’s Views

  • Today: 2
  • Past Seven Days: 4
  • All-Time: 1,241
 
Introduced
 
House
Passes
 
Senate
Passes
 
President
Signs
 

 
03/29/12
 
 
 
 
 
 
 

Official Summary

Generic Drug Application Review Fairness Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to extend from 30 to 60 months after application the period for a first applicant of a generic drug to obtain tentative approval without forfeiting the 180-day exclusivity period with resp

Official Summary

Generic Drug Application Review Fairness Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to extend from 30 to 60 months after application the period for a first applicant of a generic drug to obtain tentative approval without forfeiting the 180-day exclusivity period with respect to such drug, unless the failure in meeting the extended period is caused by a change in or review of approval requirements. Limits extension coverage to applications filed within 30 months preceding the enactment of this Act. Reduces such extended period by six months per year over a five-year period, beginning on October 1, 2013. Directs the Secretary of Health and Human Services (HHS) to maintain the Office of Generic Drugs as a separate office within the Center for Drug Evaluation and Research of the Food and Drug Administration (FDA).

...Read the Rest




Vote on This Bill

-% Users Support Bill

0 in favor / 0 opposed
 

Send Your Rep a Letter

about this bill Support Oppose Tracking
Track with MyOC