Combination Drug Development Incentive Act of 2013
Bill journey · stage 2 of 5
Under committee review
What it doesSummary 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.
What just happenedAug 2, 2013
Referred to the Subcommittee on Health.
Who’s behind it
- Introduced in HouseAug 2, 2013
- Aug 2, 2013Committee
Referred to the Subcommittee on Health.
- Aug 2, 2013IntroReferralH11100
Referred to the House Committee on Energy and Commerce.
- Aug 2, 2013IntroReferralIntro-H
Introduced in House
- Aug 2, 2013IntroReferral1000
Introduced in House