3.0.0 1906 2025-12-05T08:32:35Z 2025-12-05T08:32:35Z Senate S S 2023-06-08 118 https://www.congress.gov/bill/118th-congress/senate-bill/1906 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred To 2023-06-08T19:17:36Z 118 4408 HR 2023-07-07 Referred to the Subcommittee on Health. Identical bill CRS 2023-06-08 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2023-06-08 Introduced in Senate IntroReferral 10000 9 Library of Congress B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN N G000555 Sen. Gillibrand, Kirsten E. [D-NY] Kirsten Gillibrand D NY E. 2023-06-08 True W000437 Sen. Wicker, Roger F. [R-MS] Roger Wicker R MS F. 2023-06-08 True C001096 Sen. Cramer, Kevin [R-ND] Kevin Cramer R ND 2023-06-08 True M001153 Sen. Murkowski, Lisa [R-AK] Lisa Murkowski R AK 2023-06-08 True M001183 Sen. Manchin, Joe, III [D-WV] Joseph Manchin D WV 2023-10-18 False W000790 Sen. Warnock, Raphael G. [D-GA] Raphael Warnock D GA 2023-10-24 False V000137 Sen. Vance, J. D. [R-OH] J. Vance R OH D. 2023-11-01 False S001227 Sen. Schmitt, Eric [R-MO] Eric Schmitt R MO S. 2023-11-01 False G000359 Sen. Graham, Lindsey [R-SC] Lindsey Graham R SC 2023-11-01 False S001181 Sen. Shaheen, Jeanne [D-NH] Jeanne Shaheen D NH 2023-11-02 False P000145 Sen. Padilla, Alex [D-CA] Alex Padilla D CA 2023-11-02 False L000571 Sen. Lummis, Cynthia M. [R-WY] Cynthia Lummis R WY M. 2023-11-07 False R000618 Sen. Ricketts, Pete [R-NE] Pete Ricketts R NE 2023-11-07 False D000618 Sen. Daines, Steve [R-MT] Steve Daines R MT 2023-11-07 False C001047 Sen. Capito, Shelley Moore [R-WV] Shelley Capito R WV Moore 2023-11-08 False T000464 Sen. Tester, Jon [D-MT] Jon Tester D MT 2023-11-14 False W000800 Sen. Welch, Peter [D-VT] Peter Welch D VT 2023-12-07 False F000479 Sen. Fetterman, John [D-PA] John Fetterman D PA K. 2023-12-12 False K000393 Sen. Kennedy, John [R-LA] John Kennedy R LA 2024-01-10 False Health Administrative law and regulatory procedures 2023-11-13T13:45:37Z Civil actions and liability 2023-11-13T13:45:37Z Congressional oversight 2023-11-13T13:45:37Z Department of Health and Human Services 2023-11-13T13:45:37Z Drug safety, medical device, and laboratory regulation 2023-11-13T13:45:37Z Health information and medical records 2023-11-13T13:45:37Z Prescription drugs 2023-11-13T13:45:37Z Health 2023-07-06T21:45:16Z

00 2023-06-08 Introduced in Senate 2024-06-06T19:14:04Z <p><strong>Promising Pathway Act&nbsp;</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 2024-07-24T15:21:43Z Short Title(s) as Introduced 101 2024-05-24T13:39:00Z Introduced in Senate IS Official Title as Introduced 6 2023-07-06T12:59:02Z Introduced in Senate IS Introduced in Senate 2023-06-08T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s1906is/xml/BILLS-118s1906is.xml 2023-06-08 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.