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Enhancing Drug Safety and Innovation Act of 2007
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.
previous 110th session of congress Other Bill Titles (2 more) 3/19/2007--Introduced.
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.
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Committees
Amendments
This bill has no amendments.
Bill Status
| Introduced |  | Voted on by House | | Voted on by Senate | | Considered By President | | Bill Becomes Law |
| March 19, 2007 |
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Blog Coverage
December 31, 2008 Eye on FDA: Welcome 2009 - What's in Store for the Pharmaceutical ...
H.R. 1561 - Enhancing Drug Safety and Innovation Act of 2007 · H.R. 3 - Stem Cell Research Enhancement Act of 2007 · H.R. 331 - Drug Expiration Date Study · H.R. 380 - Pharmaceutical Market Access and Drug Safety Act of 2007 ...
Source: Eye on FDA
December 29, 2008 Eye on FDA: New Prostate Cancer Treatment Approved by FDA
H.R. 1561 - Enhancing Drug Safety and Innovation Act of 2007 · H.R. 3 - Stem Cell Research Enhancement Act of 2007 · H.R. 331 - Drug Expiration Date Study · H.R. 380 - Pharmaceutical Market Access and Drug Safety Act of 2007 ...
Source: Eye on FDA
December 26, 2008 NÅk Lapja Cafe - Minden nÅ szép konyháról álmodik
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Source: Nők Lapja Cafe
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