S.3807 - Enhancing Drug Safety and Innovation Act of 2006

A bill 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. view all titles (2)

All Bill Titles

  • Short: Enhancing Drug Safety and Innovation Act of 2006 as introduced.
  • Official: A bill 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. as introduced.

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Introduced
 
Senate
Passes
 
House
Passes
 
President
Signs
 

 
08/03/06
 
 
 
 
 
 
 

Official Summary

Enhancing Drug Safety and Innovation Act of 2006 - 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

Official Summary

Enhancing Drug Safety and Innovation Act of 2006 - 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 within the Food and Drug Administration (FDA) the Reagan-Udall Institute for Applied Biomedical Research 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 establish one or more Critical Path Institutes 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 of Health and Human Services, 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 a member of a panel advising or recommending to the Secretary regarding FDA activities to disclose any financial involvements that the member may have. Directs the Secretary to recuse members with a high magnitude of financial involvement.

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