3.0.0 4446 2022-12-29T17:48:34Z 2022-12-29T17:48:34Z Senate S 2022-06-22 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2022-06-22T18:57:59Z FDASLA Act of 2022 117 4348 S 2022-07-13 Placed on Senate Legislative Calendar under General Orders. Calendar No. 444. Related bill CRS 2022-06-22 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S3077-3078) IntroReferral 2022-06-22 Introduced in Senate IntroReferral 10000 9 Library of Congress C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. N K000384 Sen. Kaine, Tim [D-VA] Timothy Kaine D VA M. 2022-06-22 True Health Health 00 2022-06-22 Introduced in Senate 2022-10-21T20:38:39Z Modernizing the Accelerated Approval Pathway Act of 2022

This bill modifies provisions relating to the accelerated approval of drugs for serious or life-threatening diseases or conditions, including by requiring the Food and Drug Administration (FDA) to publish its reasons when it determines a postapproval study to be unnecessary. The bill also establishes a pilot program and an FDA council to support the development of drugs for rare diseases and ensure the appropriate use of the accelerated approval pathway, respectively.

]]> Modernizing the Accelerated Approval Pathway Act of 2022 Display Title Modernizing the Accelerated Approval Pathway Act of 2022 Short Title(s) as Introduced Modernizing the Accelerated Approval Pathway Act of 2022 Introduced in Senate IS Official Title as Introduced A bill to modernize the process of accelerated approval of a drug for a serious or life-threatening disease or condition. Introduced in Senate IS Introduced in Senate 2022-06-22T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s4446is/xml/BILLS-117s4446is.xml 2022-06-22 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S3077-3078) 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.