New C-Path group aims to smooth FDA-Industry Interaction Over Dx

January 7, 2009

By hammersmith

[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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