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Regulatory Standards › Emergency Use Authorization (EUA)

Morgan Lewis

China Amends Regulation Governing Medical Devices

Morgan Lewis on

China recently amended its primary regulation governing medical devices, the Regulation on Supervision and Administration of Medical Devices (2021 RSAMD), which will replace its previous 2014 version and become effective on...more

Morgan Lewis

FDA Regulation of COVID-19 Apps, Digital Therapeutics, and Other Digital Health Technologies

Morgan Lewis on

With the coronavirus (COVID-19) pandemic showing no signs of abating, many digital health developers have refocused their technical expertise to develop products for use in the pandemic, including software apps for COVID-19...more

Hogan Lovells

First emergency use authorization for COVID-19 drugs may open door for more EUAs

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) allowing distribution of two decades-old malaria drugs — Chloroquine Phosphate and Hydroxychloroquine Sulfate — to treat COVID-19. ...more

Hogan Lovells

In midst of COVID-19, FDA reminds industry that it plays both good and bad cop

Hogan Lovells on

U.S. authorities are actively policing entities making illegal promotional claims that products mitigate, prevent, treat, cure, or diagnose COVID-19....more

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