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Article: New FDA guidances aimed at reducing ‘gridlock’ of trials.
- Article from:
- Medical Device Daily
- Article date:
- July 5, 2006
CopyrightCOPYRIGHT 2006 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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New FDA guidances aimed at reducing ?gridlock? of trials
By MARK McCARTY
Medical Device Daily Washington Editor
The FDA last week released another clutch of guidances under the Critical Path Initiative, with the goal to push clinical trials along without incurring undue danger to trial subjects or in post-approval commercial use.
Dubbed the Human Subject Protection and Bioresearch Monitoring (HSP/BIMO) initiative, the accompanying press release notes that the agency wants to ?leverage existing oversight done by private entities to accomplish the agency?s risk-minimization goals.? Underlying much of the impetus behind these guidances is ...