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510(k) Review Periods Shortening for Biomarker Tests

by John Audette | Feb 07, 2014 | Analysis, Regulation

We are beginning to update our research report that analyzes commercial trends for biomarker-based tests, and one of the first numbers we looked at is the average FDA review period for 510(k) tests that use molecular biomarkers. In our last report the trend over the last decade (2002-2012) was ...

   

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