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Congressional Research Service
Version 00 · Introduced in Senate · Feb 1, 2007
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.
Showing the opening paragraphs of the official summary.
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.
People & committees
Sen. Enzi, Michael B. [R-WY] · R–WY
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Committee on Health, Education, Labor, and Pensions. Hearings held.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sponsor introductory remarks on measure. (CR S1530-1532)
Introduced in Senate
Primary sources
Text links open the official source. We currently store references to these documents.
Source last updated: Aug 14, 2025. Consult Congress.gov for the current record.
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