February 29, 2020 / 3:53 PM / a month ago

BRIEF-U.S. FDA Issues New Policy To Help Expedite Availability Of Diagnostics

Feb 29 (Reuters) - U.S. FDA:

* CORONAVIRUS (COVID-19) UPDATE: FDA ISSUES NEW POLICY TO HELP EXPEDITE AVAILABILITY OF DIAGNOSTICS

* FDA- NEW POLICY IS FOR LABS THAT DEVELOP, BEGIN TO USE VALIDATED COVID-19 DIAGNOSTICS BEFORE FDA HAS COMPLETED REVIEW OF THEIR EUA REQUESTS

* FDA- GUIDANCE ISSUED DESCRIBES A POLICY ENABLING LABS TO IMMEDIATELY USE TESTS DEVELOPED, VALIDATED TO ACHIEVE MORE RAPID TESTING CAPACITY IN U.S.

* FDA- UNDER THIS POLICY, EXPECT CERTAIN LABS WHO DEVELOP VALIDATED TESTS FOR CORONAVIRUS WOULD BEGIN USING THEM RIGHT AWAY PRIOR TO FDA REVIEW Source text for Eikon:

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