Paul Kim

Foley Hoag LLP

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Latest Posts › Emergency Use Authorization (EUA)

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FDA Issues New Guidance to Developers of COVID-19 Vaccines

On June 30, 2020, the U.S. Food and Drug Administration (FDA) released new guidance to provide recommendations for sponsors to facilitate development of SARS-CoV-2 vaccines to prevent COVID-19. The guidance highlights key...more

7/1/2020 / Clinical Trials , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Investigational New Drug Application (IND) , Manufacturers , National Institute of Health (NIH) , New Guidance , Vaccinations

FDA Issues Emergency Use Authorizations for Additional Medical Devices in Response to COVID-19

On Friday, April 10, 2020, the Food and Drug Administration (FDA) announced that it has issued two additional Emergency Use Authorizations (EUA) in response to the coronavirus pandemic: one for a device that is used to...more

4/15/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Devices , Medical Supplies , Personal Protective Equipment

Client Alert: FDA Taking Overdue Steps to Accelerate COVID-19 Diagnostic Testing

In response to the COVID-19 pandemic, and in light of the persistent shortage of diagnostic tests for the SARS-CoV-2 virus, the U.S. Food and Drug Administration (FDA) provided recent but overdue guidance on the use of its...more

3/23/2020 / Clinical Laboratories , Coronavirus/COVID-19 , Diagnostic Tests , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA)

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