3.0.0 2455 2023-01-11T13:31:20Z 2023-01-11T13:31:20Z 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. PITTS:H.R. 2455.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 1[Page H3390]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2015-05-22T15:12:49Z Referred to 2015-05-19T14:07:00Z 21st Century Cures Act 114 6 HR 2015-07-13 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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 P000373 Rep. Pitts, Joseph R. [R-PA-16] JOSEPH PITTS R PA R. 16 N Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Prescription drugs Health 00 2015-05-19 Introduced in House 2015-11-17T12:45:24Z This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to define "precision drug or biological product." (Precision medications are commonly understood to be treatments for those patients who are likely to respond to the medication based on a biomarker, which is a biological characteristic such as a genetic factor.)

The FDA must issue and periodically update guidance that addresses the development and use of biomarkers to identify the subset of patients that are likely to respond to a medication.

The FDA may rely upon data previously submitted for a different approved medication or indication to expedite the clinical development of a precision medication that has been designated for the treatment of a serious or rare condition.]]> To amend the Federal Food, Drug, and Cosmetic Act with respect to precision medicine. Display Title To amend the Federal Food, Drug, and Cosmetic Act with respect to precision medicine. Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act with respect to precision medicine. Introduced in House IH Introduced in House 2015-05-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr2455ih/xml/BILLS-114hr2455ih.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.