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Protecting human subjects focus of national FDA conference at UH

HOUSTON, March 17, 2005 New medical devices have to be tested on human subjects, but protecting the rights of those subjects can present considerable challenges for researchers. A national conference devoted to exploring the FDA critical pathway for approval of new medical products while protecting human subjects, co-sponsored by the Food and Drug Administration and the University of Houston, will be held at UH April 21-22.

One of only three annual conferences sponsored by the U.S. Department of Health and Human Services' Office of Human Research Protections (OHRP), UH is hosting "The Critical Path to New Medical Products: The Challenges in Protecting Human Subjects." The two days of presentations, panels and breakout sessions will be held at the Hilton UH Hotel and Conference Center.

"While the increased potential is tremendous for new medicines, biologicals and genomic-based treatments and devices that prevent and cure diseases, fewer new medical devices are reaching the marketplace," said Isaac D. Montoya, clinical professor in the UH College of Pharmacy. "The shortest distance between two points is a straight line; however, the line that leads to developing new medical devices is rarely short or straight. This conference will explore options and approaches for meeting this challenge while protecting human subjects."

The "critical path" of medical product development includes the process and crucial steps that determine whether and how quickly a medical discovery becomes a reliable device for patient use. With a number of challenges and issues concerning the protection of human subjects, this "critical path" will be thoroughly examined. Participants will be given practical information about conducting biomedical research, as well as being provided an update on the regulations and presented with an overview of the challenges, issues and potential solutions facing government and the private sector in conducting federally funded
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Contact: Lisa Merkl
lkmerkl@uh.edu
713-743-8192
University of Houston
17-Mar-2005


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