Wayne Matelski

Wayne Matelski

ArentFox Schiff

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Latest Posts › Department of Health and Human Services (HHS)

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Long COVID – Just the Facts

The Food and Drug practice at ArentFox Schiff has received numerous inquiries from clients about long COVID, so we decided to ask our in-house scientist, Robert Edwards, Ph.D., Director of Regulatory Science, to prepare an...more

6/15/2022  /  Affordable Care Act , Canada , Centers for Disease Control and Prevention (CDC) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Diagnostic Tests , Food and Drug Administration (FDA) , Risk Factors

EUAs for Laboratory Developed COVID-19 Tests Will No Longer Be Reviewed by the FDA

The FDA announced on October 7 that it will no longer review requests for Emergency Use Authorizations (EUAs) for COVID-19 laboratory developed tests – so called “LDTs.” This is a substantial change in Agency policy. From...more

10/12/2020  /  Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Public Readiness and Emergency Preparedness Act (PREP Act)
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