3.0.0 4408 2025-12-05T08:34:40Z 2025-12-05T08:34:40Z House H HR 2023-06-30 118 https://www.congress.gov/bill/118th-congress/house-bill/4408 <pre>[Congressional Record Volume 169, Number 114 (Friday, June 30, 2023)][House]From the Congressional Record Online through the Government Publishing Office [<a href="https://www.gpo.gov">www.gpo.gov</a>]By Mr. GALLAGHER:H.R. 4408.Congress has the power to enact this legislation pursuantto the following:The Interstate Commerce Clause: Clause 3 of Section 8 ofArticle I.The single subject of this legislation is:Pharmaceutical approval and safety[Page H3160]</pre> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2023-07-07T19:05:01Z Unknown 2023-06-30T18:08:40Z Referred To 2023-06-30T18:08:40Z 118 1906 S 2023-06-08 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Identical bill CRS 2023-07-07 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2023-06-30 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2023-06-30 Introduced in House IntroReferral Intro-H 9 Library of Congress 2023-06-30 Introduced in House IntroReferral 1000 9 Library of Congress G000579 Rep. Gallagher, Mike [R-WI-8] Mike Gallagher R WI 8 N Q000023 Rep. Quigley, Mike [D-IL-5] Mike Quigley D IL 5 2023-06-30 True W000821 Rep. Westerman, Bruce [R-AR-4] Bruce Westerman R AR 4 2023-06-30 True S001193 Rep. Swalwell, Eric [D-CA-14] Eric Swalwell D CA 14 2023-06-30 True F000466 Rep. Fitzpatrick, Brian K. [R-PA-1] Brian Fitzpatrick R PA K. 1 2023-06-30 True D000632 Rep. D'Esposito, Anthony [R-NY-4] Anthony D'Esposito R NY 4 2023-08-08 False P000616 Rep. Phillips, Dean [D-MN-3] Dean Phillips D MN 3 2023-10-26 False W000795 Rep. Wilson, Joe [R-SC-2] Joe Wilson R SC 2 2023-12-07 False G000583 Rep. Gottheimer, Josh [D-NJ-5] Josh Gottheimer D NJ 5 2023-12-07 False F000462 Rep. Frankel, Lois [D-FL-22] Lois Frankel D FL 22 2023-12-07 False G000061 Rep. Garcia, Mike [R-CA-27] Mike Garcia R CA 27 2024-04-05 False Health Administrative law and regulatory procedures 2023-11-13T13:45:34Z Civil actions and liability 2023-11-13T13:45:34Z Congressional oversight 2023-11-13T13:45:34Z Department of Health and Human Services 2023-11-13T13:45:35Z Drug safety, medical device, and laboratory regulation 2023-11-13T13:45:34Z Health information and medical records 2023-11-13T13:45:34Z Prescription drugs 2023-11-13T13:45:34Z Health 2023-08-03T22:30:28Z

00 2023-06-30 Introduced in House 2024-06-06T19:19:31Z <p><strong>Promising Pathway Act</strong></p><p>This bill provides for expedited, provisional approval of drugs for serious or life-threatening diseases or conditions.</p><p>Specifically, the bill allows for provisional approval of drugs that are used to treat, prevent, or diagnose a serious or life-threatening disease or condition for which premature death is likely without early medical intervention. The Food and Drug Administration (FDA) must evaluate applications within 90 days of receipt. The FDA may approve applications if there is early evidence, including real-world and real-time evidence, of the drug's efficacy, as well as substantial evidence of the drug's safety. Provisional approval is valid for two years and may be renewed for up to eight years. The FDA may withdraw provisional approval in the event of serious adverse health effects.&nbsp;</p><p>Drug sponsors that receive provisional approval must require all patients receiving the drug to participate in an observational registry, through which the drug sponsor may collect and submit data relating to the drug until it is fully approved. Registries may be operated by the drug sponsor or another entity. The FDA must annually review these registries; sponsors of registries that fail to meet the bill's requirements are subject to civil penalties.&nbsp;</p><p>&nbsp;</p>

Display Title 45 2024-06-11T15:45:56Z Short Title(s) as Introduced 101 2024-05-24T13:38:06Z Introduced in House IH Official Title as Introduced 6 2024-03-18T21:05:48Z Introduced in House IH Introduced in House 2023-06-30T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118hr4408ih/xml/BILLS-118hr4408ih.xml 2023-07-07 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.