H.R. 4332 · 112th Congress
Generic Drug Application Review Fairness Act of 2012
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Never voted on. It didn't reach a floor vote before the 112th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
PalloneSponsor6 cosponsors · 3 D, 3 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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…
What it does: CRS summary · Introduced in House · Mar 29, 2012
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).
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Generic Drug Application Review Fairness Act of 2012
Latest action (Mar 30, 2012): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Mar 29, 2012
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.