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Enhancing Drug Safety and Innovation Act of 2007

Introduced: March 19, 2007 See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 20, 2007
Referred to the Subcommittee on Health.
Mar 19, 2007
Referred to the House Committee on Energy and Commerce.
Mar 19, 2007
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now March 20, 2007

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2