S.484 - Enhancing Drug Safety and Innovation Act of 2007110th Congress (2007-2008)
|Sponsor:||Sen. Enzi, Michael B. [R-WY] (Introduced 02/01/2007)|
|Committees:||Senate - Health, Education, Labor, and Pensions|
|Latest Action:||Senate - 03/14/2007 Committee on Health, Education, Labor, and Pensions. Hearings held. (All Actions)|
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Summary: S.484 — 110th Congress (2007-2008)All Information (Except Text)
Introduced in Senate (02/01/2007)
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.
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.