3.0.0 3839 2024-07-24T15:21:45Z 2024-07-24T15:21:45Z House H HR 2023-06-06 118 [Congressional Record Volume 169, Number 98 (Tuesday, June 6, 2023)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. DUNN of Florida:H.R. 3839.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, clause 3 provides Congress with thepower ``to regulate commerce with foreign nations, and amongthe several states, and with the Indian tribes.''The single subject of this legislation is:This bill alters the FDA review process for complex genericdrug applications.[Page H2763]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2023-06-09T18:17:34Z Referred to 2023-06-06T14:01:25Z PATIENT Act of 2023 118 3561 HR 2023-05-24 Ordered to be Reported (Amended) by the Yeas and Nays: 49 - 0. Related bill CRS Increasing Transparency in Generic Drug Applications Act 118 775 S 2023-03-14 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS Expanding Access to Low-Cost Generics Act of 2023 118 1114 S 2023-06-22 Placed on Senate Legislative Calendar under General Orders. Calendar No. 108. Related bill CRS Lower Costs, More Transparency Act 118 5378 HR 2023-12-11 Motion to reconsider laid on the table Agreed to without objection. 19:13:20 Related bill CRS 2023-06-09 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2023-06-06 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2023-06-06 Introduced in House IntroReferral Intro-H 9 Library of Congress 2023-06-06 Introduced in House IntroReferral 1000 9 Library of Congress D000628 Rep. Dunn, Neal P. [R-FL-2] Neal Dunn R FL P. 2 N K000382 Rep. Kuster, Ann M. [D-NH-2] Ann Kuster D NH M. 2 2023-06-06 True Health Administrative law and regulatory procedures 2023-10-11T19:30:24Z Department of Health and Human Services 2023-10-11T19:30:24Z Drug safety, medical device, and laboratory regulation 2023-10-11T19:30:24Z Prescription drugs 2023-10-11T19:30:24Z Health 2023-07-06T19:30:24Z 00 2023-06-06 Introduced in House 2023-10-03T15:46:31Z

This bill requires the Food and Drug Administration (FDA) to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). The FDA must also update or publish guidance on how it makes such determinations.

]]> To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Display Title 45 To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. 2024-07-24T15:21:45Z Official Title as Introduced 6 To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. 2024-03-18T20:57:11Z Introduced in House IH Introduced in House 2023-06-06T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118hr3839ih/xml/BILLS-118hr3839ih.xml 2023-06-09 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.