3.0.0 1778 2023-01-11T13:17:44Z 2023-01-11T13:17:44Z Senate S S 2009-10-14 111 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2009-10-14T15:19:28Z 2009-10-14 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2009-10-14 Sponsor introductory remarks on measure. (CR S10436-10437) IntroReferral B00100 9 Library of Congress 2009-10-14 Introduced in Senate IntroReferral 10000 9 Library of Congress S001181 Sen. Shaheen, Jeanne [D-NH] Jeanne Shaheen D NH N V000127 Sen. Vitter, David [R-LA] David Vitter R LA 2009-10-14 True B001265 Sen. Begich, Mark [D-AK] Mark Begich D AK 2009-11-02 False Health Consumer affairs Drug safety, medical device, and laboratory regulation Prescription drugs Health

00 2009-10-14 Introduced in Senate 2010-02-26T22:26:49Z Access to Affordable Medicines Act - Amends the Federal Food, Drug, and Cosmetic Act to provide that an application for a generic drug the proposed labeling of which is different from the labeling at the time the Secretary of Health and Human Services (HHS) evaluates the application shall be eligible for approval (and such drug shall not be considered misbranded) if: (1) the revision has been approved by the Secretary within 60 days of the expiration of the patent or exclusivity period for the drug; (2) the Secretary has not determined the applicable labeling text when such period expires; (3) the labeling revision does not include a change to the warnings section; (4) the Secretary does not deem that the continued presence in commerce of the labeling before the revision adversely impacts the safe use of the drug; and (5) the sponsor of the application agrees to submit revised labeling not later than 60 days after the notification of any changes required by the Secretary.

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Display Title Official Title as Introduced Introduced in Senate IS Short Titles as Introduced Introduced in Senate 2009-10-14T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111s1778is/xml/BILLS-111s1778is.xml 2009-10-14 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.