3.0.0 843 2025-03-28T17:46:13Z 2025-03-28T17:46:13Z House H HR 2025-01-31 119 <pre>[Congressional Record Volume 171, Number 21 (Friday, January 31, 2025)][House]From the Congressional Record Online through the Government Publishing Office [<a href="https://www.gpo.gov">www.gpo.gov</a>]By Ms. BARRAGAN:H.R. 843.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8 of the United States Constitution[Page H433]</pre> hsif00 Energy and Commerce Committee House Standing Referred To 2025-01-31T15:02:00Z 2025-01-31 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2025-01-31 Introduced in House IntroReferral Intro-H 9 Library of Congress 2025-01-31 Introduced in House IntroReferral 1000 9 Library of Congress B001300 Rep. Barragán, Nanette Diaz [D-CA-44] Nanette Barragán D CA Diaz 44 N Health Health 2025-03-04T13:15:22Z

00 2025-01-31 Introduced in House 2025-03-28T17:45:23Z <p><strong>Prompt Approval of Safe Generic Drugs Act</strong></p><p>This bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a generic drug despite the omission of certain safety information from the generic drug's labeling.</p><p>Specifically, the FDA may not deem an abbreviated application for approval of a generic drug ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's patent or exclusivity protections. Similarly, a drug that is approved under this bill may not be considered mislabeled for lacking such safety information.</p><p>Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug (i.e., a generic drug). Currently,&nbsp;the labeling for such a generic drug must generally be identical to that of the already-approved drug. This bill provides an exception to that requirement under the specified circumstances.&nbsp;</p><p>For any drug approved under this bill, the FDA must require the drug's labeling to include any safety information that is necessary to assure safe use.</p>

Display Title 45 2025-02-28T05:23:22Z Short Title(s) as Introduced 101 2025-02-28T05:23:19Z Introduced in House IH Official Title as Introduced 6 2025-02-28T05:18:36Z Introduced in House IH Introduced in House 2025-01-31T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-119hr843ih/xml/BILLS-119hr843ih.xml 2025-01-31 Referred to the House Committee on Energy and Commerce. 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.