Stacy Cline Amin on Coronavirus/COVID-19

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

FDA Will Once Again Accept Pre-Submissions For All In Vitro Diagnostic Tests

The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions for all in vitro diagnostic (IVD)...more

6/6/2022 / CDRH , Coronavirus/COVID-19 , Diagnostic Tests , Federal Register , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Public Health

CURES 2.0: WILL IT BE BETTER THAN THE ORIGINAL?

It’s summer blockbuster season and that means sequels abound. Now it seems that the U.S. Congress wants in on the action. Just five years after Congress passed the 21st Century Cures Act, a bipartisan group of...more

7/27/2021 / 21st Century Cures Act , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Innovation , National Institute of Health (NIH) , Title IV

Stacy Cline Amin

Morrison & Foerster LLP

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