H.R. 2985 · 113th Congress
Combination Drug Development Incentive Act of 2013
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Never voted on. It didn't reach a floor vote before the 113th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
ChaffetzSponsor4 cosponsors · 1 D, 3 R
2 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Combination Drug Development Incentive Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act with respect to the five-year bar on a new drug application (or abbreviated drug application) by anyone that has not obtained a right of reference or use from the original and approved drug approval applicant by or for whom investigations under the original,…
What it does: CRS summary · Introduced in House · Aug 2, 2013
Combination Drug Development Incentive Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act with respect to the five-year bar on a new drug application (or abbreviated drug application) by anyone that has not obtained a right of reference or use from the original and approved drug approval applicant by or for whom investigations under the original, subsequently approved application were conducted.
Applies this five-year bar, and the requirement of a grant of a right of reference or use, with respect to an approved drug application (or abbreviated drug application) if: (1) the application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant, (2) the application is for a drug which contains a combination of active ingredients (combination drug), and (3) no such combination of active ingredients has been approved in any other application.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Combination Drug Development Incentive Act of 2013
Latest action (Aug 2, 2013): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Aug 2, 2013
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.