3.0.0 660 2022-11-01T17:03:24Z 2022-11-01T17:03:24Z Senate S 2019-03-05 116 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2019-03-05T22:24:07Z 2019-03-05 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2019-03-05 Introduced in Senate IntroReferral 10000 9 Library of Congress B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN N Health Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Government information and archives Health 00 2019-03-05 Introduced in Senate 2021-09-13T15:23:16Z Efficiency and Transparency in Petitions Act

This bill requires a petition regarding a pending generic drug or biological product application to be submitted to the Food and Drug Administration (FDA)within one year of when the petitioner discovers the issue that is the basis for the petition.

The FDA may grant a waiver of the one-year deadline.

]]> Efficiency and Transparency in Petitions Act Display Title Efficiency and Transparency in Petitions Act Short Title(s) as Introduced Efficiency and Transparency in Petitions Act Introduced in Senate IS Official Title as Introduced A bill to address abuse of the Food and Drug Administration's citizen petition process by brand drug manufacturers. Introduced in Senate IS Introduced in Senate 2019-03-05T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s660is/xml/BILLS-116s660is.xml 2019-03-05 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.