3.0.0 2416 2023-01-11T13:31:22Z 2023-01-11T13:31:22Z House HR 2015-05-19 114 [Congressional Record Volume 161, Number 77 (Tuesday, May 19, 2015)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. BURGESS:H.R. 2416.Congress has the power to enact this legislation pursuantto the following:Per Section 8, Clause 1 of the Constitution, Congress shallhave the power to lay and collect taxes. Per the Section 8,Clause 3 of the Constitution, Congress shall have the powerregulate Commerce with foreign Nations and among the severalStates.[Page H3389]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2015-05-22T19:48:59Z Referred to 2015-05-19T14:03:25Z 21st Century Cures Act 114 34 HR 2016-12-13 Became Public Law No: 114-255. Related bill CRS 2015-05-22 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2015-05-19 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2015-05-19 Introduced in House IntroReferral Intro-H 9 Library of Congress 2015-05-19 Introduced in House IntroReferral 1000 9 Library of Congress B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 N Health Drug safety, medical device, and laboratory regulation Government information and archives Health information and medical records Health 00 2015-05-19 Introduced in House 2015-10-28T20:44:12Z 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.]]> 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. Display 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. Official Title as Introduced 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. Introduced in House IH Introduced in House 2015-05-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr2416ih/xml/BILLS-114hr2416ih.xml 2015-05-22 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.