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rawman

04/06/20 9:40 PM

#67281 RE: jerzybondon #67273

In PR it states Pre-UEA not Pre-EUA. What's the difference?


NO DIFFERENCE! CEO KEITH BERMAN MISSPELLED IT! I POINTED THIS OUT IN A POST EARLIER THIS MORNING! HERE'S THE PROOF DIRECTLY FROM THE FDA WEBSITE?

About Pre-EUA

To help prepare for potential and current emergencies, FDA works with medical countermeasure developers to prepare Pre-EUA packages, when appropriate. A Pre-EUA package contains data and information about the safety, quality, and efficacy of the product, its intended use under a future or current EUA, and information about the emergency or potential emergency situation. The pre-EUA process allows FDA scientific and technical subject matter experts to begin a review of information and assist in the development of conditions of authorization, fact sheets, and other documentation that would be needed for an EUA in advance of an emergency and also helps to facilitate complete EUA requests during a current emergency declaration.


https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/how-submit-pre-eua-vitro-diagnostics-fda

FYI, today is not the first time CEO Berman has misspelled the "EUA" acronym!