3.0.0 1561 2023-01-11T19:51:33Z 2023-01-11T19:51:33Z House H HR 2007-03-19 110 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2007-03-20T19:50:57Z Referred to 2007-03-19T16:30:30Z Enhancing Drug Safety and Innovation Act of 2007 110 484 S 2007-03-14 Committee on Health, Education, Labor, and Pensions. Hearings held. Related bill CRS 2007-03-20 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2007-03-19 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2007-03-19 Introduced in House IntroReferral Intro-H 9 Library of Congress 2007-03-19 Introduced in House IntroReferral 1000 9 Library of Congress W000215 Rep. Waxman, Henry A. [D-CA-30] HENRY WAXMAN D CA A. 30 N M000133 Rep. Markey, Edward J. [D-MA-7] Edward Markey D MA J. 7 2007-03-19 True F000116 Rep. Filner, Bob [D-CA-51] BOB FILNER D CA 51 2007-04-24 False M000312 Rep. McGovern, James P. [D-MA-3] JAMES MCGOVERN D MA P. 3 2007-05-07 False E000215 Rep. Eshoo, Anna G. [D-CA-14] ANNA ESHOO D CA G. 14 2007-05-09 False M001143 Rep. McCollum, Betty [D-MN-4] BETTY MCCOLLUM D MN 4 2007-05-14 False G000551 Rep. Grijalva, Raúl M. [D-AZ-7] Raúl Grijalva D AZ M. 7 2007-05-15 False M000725 Rep. Miller, George [D-CA-7] GEORGE MILLER D CA 7 2007-05-15 False G000309 Rep. Gordon, Bart [D-TN-6] BART GORDON D TN 6 2007-05-16 False M001169 Rep. Murphy, Christopher [D-CT-5] Christopher Murphy D CT S. 5 2007-05-21 False A000357 Rep. Allen, Thomas H. [D-ME-1] THOMAS ALLEN D ME H. 1 2007-06-05 False A000014 Rep. Abercrombie, Neil [D-HI-1] NEIL ABERCROMBIE D HI 1 2007-06-05 False C001068 Rep. Cohen, Steve [D-TN-9] Steve Cohen D TN 9 2007-06-18 False Health Biomedical engineering Clinical trials Commerce Conflict of interests Data banks Directories Drug approvals Drug industry Drugs Federal advisory bodies Government Operations and Politics Government paperwork Health information systems Health surveys Labeling Medical ethics Medical innovations Medical research Medical supplies Nonprofit organizations Product safety Research centers Risk Science, Technology, Communications Social Welfare Health 00 2007-03-19 Introduced in House 2007-06-04T19:56:16Z 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 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 House IH Display Title Enhancing Drug Safety and Innovation Act of 2007 Short Titles as Introduced Enhancing Drug Safety and Innovation Act of 2007 Introduced in House 2007-03-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr1561ih/xml/BILLS-110hr1561ih.xml 2007-03-20 Referred to the Subcommittee on Health. 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.