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H.R. 4332, The Generic Drug Application Review Fairness Act of 2012
- This item is from the 112th Congress (2011-2012) and is no longer current. Comments, voting, and wiki editing have been disabled, and the cost/savings estimate has been frozen.
H.R. 4332 would 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.