H.R. 2416 · 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act to evaluate the potential use of evidence from clinical…
Full title
To amend the Federal Food, Drug, and Cosmetic Act to evaluate the potential use of evidence from clinical experience to help support the approval of new indications for approved drugs, and for other purposes.
Key: what the circles and colors mean
Each circle is a bill. The ring fills as it moves through Congress:
Under the number: the Yea · Nay count of its final (or latest) recorded vote. On a member's page, the small badge is how that member voted: Y Yea / Aye, N Nay / No, P Present, – Not voting.
Gold and violet are only for Yea and Nay; they never mean a party. A member's party is the letter on their photo.
Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
BurgessSponsorNo cosponsors.
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a program to evaluate the potential use of evidence from clinical experience to support the approval of a new indication for an approved drug and to support post-approval study requirements.
What it does: CRS summary · Introduced in House · May 19, 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a program to evaluate the potential use of evidence from clinical experience to support the approval of a new indication for an approved drug and to support post-approval study requirements.
"Evidence from clinical experience" means data from sources other than randomized clinical trials, including from observational studies, registries, and therapeutic use.
Before implementing the program, the FDA must establish a draft framework for the program that describes current sources of data from clinical experience, gaps in current data collection activities, standards and methodologies for collection and analysis of data from clinical experience, and priority areas, remaining challenges, and potential pilot opportunities that the program will address.
The FDA must use the program to inform guidance to industry on the collection and use of evidence from clinical experience.Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: To amend the Federal Food, Drug, and Cosmetic Act to evaluate the potential use of evidence from clinical experience to help support the approval of new indications for approved drugs, and for other purposes.
Latest action (May 22, 2015): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: May 19, 2015
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.