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New C-Path group aims to smooth FDA-Industry Interaction Over DxTags: c-path, diagnostics, drug development
[Source: Turna Ray, Pharmacogenomics Reporter] - The Critical Path Institute plans to launch a new organization in the coming months to assess the performance of diagnostics before they are submitted to the US Food and Drug Administration for evaluation, according to a C-Path Institute official.
The new non-governmental, non-profit organization, which would provide a non-required test evaluation service to companies and have no enforcement power, will also aim to help smooth the regulatory interaction between diagnostic companies and the agency. It also could potentially help clear up confusion over regulations governing multi-analyte tests.
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Now available: “Arizona’s Bioscience Roadmap 2014-2025: Advancing the Biosciences and Improving Health Outcomes,” is now available along with its supplement, “Summary of Goals, Strategies, and Potential Actions.” An overview by Walter Plosila, Ph.D., Battelle senior advisor, is also available. The updated Roadmap provides a long-term strategy for Arizona to achieve bioscience success over the next decade.