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QUOTED. 6 April 2020. Bethany Hills.

Executive Summary

Diagnostics company Bodysphere had to retract an announcement that it had received an emergency use authorization from the US FDA for a COVID-19 serologic test. See why Bethany Hills, an attorney with law firm Morrison & Foerster, says this may be a cautionary tale for other manufacturers.

“Do not release any press releases until you have the EUA letter in hand. The second you have it you can release every press release you want, and the FDA will put up the announcement on their website in a few hours.” – Bethany Hills, partner, Morrison & Foerster

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