3.0.0 3532 2025-12-05T08:18:52Z 2025-12-05T08:18:52Z House H HR 2023-05-18 118 https://www.congress.gov/bill/118th-congress/house-bill/3532 <pre>[Congressional Record Volume 169, Number 84 (Thursday, May 18, 2023)][House]From the Congressional Record Online through the Government Publishing Office [<a href="https://www.gpo.gov">www.gpo.gov</a>]By Mr. ROY:H.R. 3532.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8The single subject of this legislation is:Healthcare[Page H2459]</pre> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2023-05-19T18:08:42Z Referred To 2023-05-18T13:09:20Z hsru00 Rules Committee House Standing Referred To 2023-05-18T13:09:25Z 118 1712 S 2023-05-18 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2023-05-19 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2023-05-18 Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsru00 Rules Committee 2023-05-18 Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2023-05-18 Introduced in House IntroReferral Intro-H 9 Library of Congress 2023-05-18 Introduced in House IntroReferral 1000 9 Library of Congress R000614 Rep. Roy, Chip [R-TX-21] Chip Roy R TX 21 N Health Congressional oversight 2023-07-07T19:45:24Z Drug safety, medical device, and laboratory regulation 2023-07-07T19:45:24Z Health 2023-06-14T18:30:24Z

00 2023-05-18 Introduced in House 2023-10-13T19:32:40Z <p><b>Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of </b><b>2023</b></p> <p>This bill establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country and there is an unmet need. </p> <p>Specifically, in order to receive reciprocal approval, the bill requires the product's sponsor to demonstrate, among other things, that (1) the product has been approved in one of the specified countries, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.</p> <p>The FDA may decline approval if the FDA determines that the product is not safe or effective. The FDA may condition reciprocal approval on the conduct of postmarket studies.</p> <p>The FDA must issue a decision on whether to grant a request for reciprocal marketing approval within 30 days of receiving the request. </p> <p>Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.</p>

Display Title 45 2024-07-24T15:21:59Z Short Title(s) as Introduced 101 2024-05-24T13:39:37Z Introduced in House IH Official Title as Introduced 6 2024-03-18T20:51:05Z Introduced in House IH Introduced in House 2023-05-18T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118hr3532ih/xml/BILLS-118hr3532ih.xml 2023-05-19 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.