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FDA Plan To Regulate Lab-Developed Tests Includes Long Phase-In, Unmet-Need Exceptions

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA said its new plan, which can’t be released as a formal draft guidance for another 60 days, would establish a more level playing field between test-kit makers and labs, while being flexible when there is not an FDA-approved alternative to an lab-developed test.

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