Stacy Cline Amin

Morrison & Foerster LLP

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Latest Posts › Emergency Use Authorization (EUA)

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New FDA Guidance On COVID-19 Vaccines

Last week, the U.S. Food and Drug Administration (FDA) published its new guidance on the Development and Licensure of Vaccines to Prevent COVID-19 (the “Guidance”). FDA provided a preview of a new COVID-19 vaccines guidance...more

10/25/2023 / Clinical Trials , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , New Guidance , Vaccinations

FDA Issues Final Transition Guidances For COVID-19 Devices

This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or...more

3/31/2023 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Devices , Public Health Emergency

Ending The COVID-19 Public Health Emergency – What Happens Next

The Biden administration announced on January 30, 2023, that it plans to terminate the COVID-19 public health emergency declaration (the “PHE declaration”) on May 11, 2023. COVID-19 EUA medical products and policies- As FDA...more

2/17/2023 / Coronavirus/COVID-19 , Drug Treatment , Emergency Use Authorization (EUA) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Joe Biden , Medicare , Public Health Emergency

FDA Updates COVID-19 Testing Guidances

The U.S. Food & Drug Administration (FDA) issued two new versions of guidance documents for COVID-19 tests on January 12, 2023: Policy for Coronavirus Disease-2019 Tests (the “COVID-19 Test Guidance”) and Policy for...more

1/25/2023 / Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Guidance Update , Public Health Emergency , Virus Testing

New Opportunities For Test Developers: Monkeypox Diagnostics

For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products....more

9/26/2022 / CDRH , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Diagnostic Tests , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Public Health , Public Health Emergency

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