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11 Apr 2013

FDA review periods extending for IVD tests

A report has suggested FDA review periods for biomarker-based IVD tests are getting longer.

The US Food and Drug Administration review periods for molecular biomarker IVD tests have been lengthening, according to a new report.
Published by Amplion Research, the report takes into account a number of variables, including the selection of the FDA committee set to conduct the review.
The report breaks down the factors that could impact on the length of a review, such as the number of targets in a test and the amount of predictable devices cited for a 510(k) test.
Science director at Amplion Research, Dr Adam Carroll, commented: "Our analysis uncovered significant variability in review products but the overall lengthening trend is clear."
In addition to analysis of review periods, the report also takes into account the markets for biomarker-based IVDs.
Indeed, executives and directors in regulatory product development and marketing positions at diagnostics and therapeutics companies could find the outcomes of the report useful, Amplion Research's business director John Audette claimed.


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