HR 1561 · 110th Congress · Health
Enhancing Drug Safety and Innovation Act of 2007
Bill Progress
✓
Introduced2
Committee3
House Vote4
Senate5
EnactedLatest: Referred to the Subcommittee on Health.(2007-03-20)
Plain Language Summary
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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 t…
Summarized by Claude AI · Non-partisan · For informational purposes only
Cosponsors (12)
12 Democrats