3.0.0 3387 2023-01-11T13:33:32Z 2023-01-11T13:33:32Z Senate S 2016-09-22 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2016-09-22T18:20:24Z 2016-09-22 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2016-09-22 Introduced in Senate IntroReferral 10000 9 Library of Congress C001095 Sen. Cotton, Tom [R-AR] Tom Cotton R AR N Health Health 00 2016-09-22 Introduced in Senate 2017-05-16T19:52:59Z Safely Advancing Valuable and Inexpensive New Generic Solutions Act or the SAVINGS Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to prioritize the review of certain generic drug applications and act on them within 150 days. This generic fast track review applies to applications for drugs: (1) that are not under patent or for which patents will expire soon, (2) for which there is no marketing exclusivity in effect, and (3) for which a generic has not recently been introduced to the market by more than one manufacturer.

The FDA must report on applications subject to generic fast track review and provide an annual accounting of how it has spent generic drug user fees.]]> SAVINGS Act Display Title SAVINGS Act Official Title as Introduced A bill to provide for the fast track review of certain generic drugs. Introduced in Senate IS Short Titles as Introduced SAVINGS Act Short Titles as Introduced Safely Advancing Valuable and Inexpensive New Generic Solutions Act Introduced in Senate 2016-09-22T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s3387is/xml/BILLS-114s3387is.xml 2016-09-22 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.