3.0.0 484 2023-01-11T19:59:06Z 2023-01-11T19:59:06Z Senate S S 2007-02-01 110 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Hearings by 2007-03-14T18:48:56Z Referred to 2007-02-01T23:14:53Z Enhancing Drug Safety and Innovation Act of 2007 110 1561 HR 2007-03-20 Referred to the Subcommittee on Health. Related bill CRS 2007-03-14 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Hearings held. Committee 2007-02-01 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2007-02-01 Sponsor introductory remarks on measure. (CR S1530-1532) IntroReferral B00100 9 Library of Congress 2007-02-01 Introduced in Senate IntroReferral 10000 9 Library of Congress E000285 Sen. Enzi, Michael B. [R-WY] MICHAEL ENZI R WY B. N K000105 Sen. Kennedy, Edward M. [D-MA] EDWARD KENNEDY D MA MOORE 2007-02-01 True Health Biomedical engineering Clinical trials Commerce Conflict of interests Congress Congressional reporting requirements Corporations Data banks Department of Health and Human Services Drug approvals Drug industry Drug interactions Drug utilization Drugs Executive reorganization Federal advisory bodies Finance and Financial Sector Financial disclosure Food and Drug Administration (FDA) Generic drugs Government Operations and Politics Government paperwork Government publicity Health information systems Labeling Medical supplies Medical technology Nonprofit organizations Pharmaceutical research Product development Product safety Research centers Risk Science, Technology, Communications Social Welfare Technological innovations Health 00 2007-02-01 Introduced in Senate 2007-03-23T15:06:29Z Enhancing Drug Safety and Innovation Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include: (1) labeling for the drug for use by health care providers; (2) submission of reports for the drug; and (3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug.

Establishes a Drug Safety Oversight Board.

Requires the Secretary of Health and Human Services to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product safety. Requires the Institute to have a Board of Directors. Allows the Board to coordinate and collaborate with other entities to conduct research, education, and outreach and to modernize the sciences of developing, manufacturing, and evaluating the safety and effectiveness of diagnostics, devices, biologics, and drugs.

Amends the Public Health Service Act to require the Secretary, acting through the Director of the National Institutes of Health (NIH), to establish and administer a clinical trial registry database and a clinical trial results database. Requires a responsible part for a clinical trial to submit clinical trial information to the Director for inclusion in the databases.

Requires each individual under consideration for a term on an advisory committee providing advice or recommendations to the Secretary regarding FDA activities to disclose industry financial interests.

]]> Enhancing Drug Safety and Innovation Act of 2007 Official Title as Introduced A bill to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes. Introduced in Senate IS Display Title Enhancing Drug Safety and Innovation Act of 2007 Short Titles as Introduced Enhancing Drug Safety and Innovation Act of 2007 Introduced in Senate 2007-02-01T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s484is/xml/BILLS-110s484is.xml 2007-03-14 Committee on Health, Education, Labor, and Pensions. Hearings held. 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.