3.0.0 930 2020-02-10T17:00:21Z 2020-02-10T17:00:21Z Senate S S 2005-04-27 109 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2005-04-27T21:02:31Z Food and Drug Administration Safety Act of 2005 109 4429 HR 2005-12-02 Referred to the Subcommittee on Health. Identical bill CRS 2005-04-27 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2005-04-27 Sponsor introductory remarks on measure. (CR S4426-4427) IntroReferral B00100 9 Library of Congress 2005-04-27 Introduced in Senate IntroReferral 10000 9 Library of Congress G000386 Sen. Grassley, Chuck [R-IA] Charles Grassley R IA E. N D000388 Sen. Dodd, Christopher J. [D-CT] CHRISTOPHER DODD D CT JOHN 2005-04-27 True C000567 Sen. Cochran, Thad [R-MS] Thad Cochran R MS 2005-04-28 False C001040 Sen. Chafee, Lincoln [R-RI] LINCOLN CHAFEE R RI D. 2005-05-25 False B000468 Sen. Bingaman, Jeff [D-NM] JESSE BINGAMAN D NM FRANCIS 2005-07-19 False M000702 Sen. Mikulski, Barbara A. [D-MD] BARBARA MIKULSKI D MD ANN 2006-05-04 False R000361 Sen. Rockefeller, John D., IV [D-WV] JAY ROCKEFELLER D WV 2006-06-16 False J000177 Sen. Johnson, Tim [D-SD] TIM JOHNSON D SD 2006-09-20 False Health Administrative remedies Advertising Biomedical engineering Clinical trials Commerce Congress Congressional reporting requirements Consumer education Cost effectiveness Data banks Department of Health and Human Services Drug adulteration Drug approvals Drug industry Epidemiology Executive reorganization Federal advisory bodies Finance and Financial Sector Fines (Penalties) Food and Drug Administration (FDA) Government Operations and Politics Government paperwork Government publicity Health information systems Law Licenses Medical supplies Pharmaceutical research Product safety Risk Sales promotion Science, Technology, Communications Health 00 2005-04-27 Introduced in Senate 2005-06-21T20:11:10Z Food and Drug Administration Safety Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Drug Evaluation and Research within the Food and Drug Administration (FDA).

Requires the Director of the Center to conduct activities to ensure the safety and effectiveness of FDA-approved drugs and licensed biological products, including by: (1) conducting postmarket risk assessment and surveillance of such drugs and products; (2) determining whether a postmarket study is required; (3) contracting, or requiring the sponsor of such a drug or product to contract, with the holders of domestic and international surveillance databases to conduct epidemiologic and other observational studies; (4) determining whether a drug or product may present an unreasonable risk to the health of patients or the general public; (5) taking corrective action if such an unreasonable risk may exist; and (6) making information about the safety and effectiveness of such drugs and biological products available to the public and health care providers in a timely manner.

Requires the Drug Safety and Risk Management Drug Advisory Committee to make recommendations to the Director on postmarket studies, drugs and biological products that may present an unreasonable risk, and appropriate corrective actions.

Allows the Secretary of Health and Human Services to assess civil penalties for violations of this Act.

Allows the Director to withdraw or suspend approval of a drug or license for a biological product using expedited procedures under certain circumstances.

Transfers to the Center the functions and duties of the Office of Drug Safety.

]]> Food and Drug Administration Safety Act of 2005 Short Titles as Introduced Food and Drug Administration Safety Act of 2005 Display Title Food and Drug Administration Safety Act of 2005 Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. Introduced in Senate 2005-04-27T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-109s930is/xml/BILLS-109s930is.xml 2005-04-27 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.