May 5, 2020 / 12:26 AM / a month ago

BRIEF-FDA -Commercial Manufacturers Will Now Submit Eua Requests On Antibody Tests Within 10 Business Days From Notifying FDA Of Validation Testing

May 4 (Reuters) - FDA:

* FDA -COMMERCIAL MANUFACTURERS WILL NOW SUBMIT EUA REQUESTS ON ANTIBODY TESTS WITHIN 10 BUSINESS DAYS FROM DATE THEY NOTIFIED FDA OF VALIDATION TESTING

* FDA -PROVIDED SPECIFIC PERFORMANCE THRESHOLD RECOMMENDATIONS POLICY ON ANTIBODY TESTS FOR SPECIFICITY & SENSITIVITY FOR ALL SEROLOGY TEST DEVELOPERS

* FDA -INTRODUCING A MORE STREAMLINED PROCESS TO SUPPORT EUA SUBMISSIONS AND REVIEW

* FDA - 2 VOLUNTARY EUA TEMPLATES FOR ANTIBODY TESTS MADE AVAILABLE, FOR COMMERCIAL MANUFACTURERS & FOR CLIA CERTIFIED LABS SEEKING FDA AUTHORIZATION

* FDA - EVEN HIGH-PERFORMING ANTIBODY TEST WHEN USED ON THOSE IN POPULATION NOT HAVING MANY COVID-19 CASES MAY SHOW AS MANY OR MORE FALSE RESULTS AS TRUE RESULTS

* FDA - MAY BE NECESSARY FOR SOME INDIVIDUALS TO HAVE TWO SEROLOGY TESTS PERFORMED TO GENERATE RELIABLE RESULTS Source text for Eikon:

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