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Biomedical Market Newsletter back issues
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FDA Center for Devices & Radiological Health announces plans for 2008.(News & Analysis)
January 1, 2008... The US DHHS Food & Drug Administration Center for Devices & Radiological Health (CDRH) is considering developing various regulatory guidance documents in fiscal year 2008:
* Guidance on MDUFMA Reauthorization
--30-Day Notices & 135-Day PMA Supplements
--FDA & Industry Actions on...
FDA Strategic Action Plan released.
January 1, 2008... Fall 2007
Message from the FDA Commissioner:
I am proud to present the FDA's Strategic Action Plan, which sets forth our long-term strategic goals and objectives. The plan also details specific actions we are committed to taking over the next 18 months as we carry out our mission of...
Health care 20 years from now.
January 1, 2008... Fall 2007
Highlights of a forum convened by David M. Walker US Comptroller General
As Comptroller General of the US, I am afforded a mixed blessing. On the one hand, I am burdened with TMI (too much information) regarding the future of this country's federal fiscal condition and...
FDA Critical Path Initiative becomes a high priority project.
January 1, 2008... Senate Field Hearing
University of Utah
Salt Lake City UT
June 01 2007; Edited version
One of the FDA's highest priority projects is the Critical Path Initiative. This project has the potential to transform the way medical products in the US are designed, developed, tested...
State of the FDA.(United States. Food and Drug Administration)
January 1, 2008... April 12 2007; Edited version Bethesda MD
I would like to assess, in rather frank terms, the state of the FDA today. I want to provide you a sense of what it feels like inside this venerable, and potentially vulnerable, guardian of the public health.
I want to do this because, in the...