Susan Lee

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Latest Posts › Coronavirus/COVID-19

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The Long (Un)Winding Road, Part 2: The FDA’s Final Transition Guidances for COVID-19 Devices

In early 2023, the Biden administration announced and set into motion its plans to wind down a number of pandemic-related programs and allow the COVID-19 public health emergency (PHE) declaration, which has been in effect...more

4/18/2023 / Biden Administration , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , New Guidance , Public Health , Public Health Emergency

The Long (Un)Winding Road: FDA Maps Out How the End of the Public Health Emergency Will Impact its COVID-19 Policies

Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be available to manufacturers of medical...more

3/16/2023 / Biden Administration , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Food Safety , Guidance Documents , Medical Devices , Prescription Drugs , Public Health Emergency , Virus Testing

Planning for the End: FDA Issues Draft Guidance for Transitioning EUA and Enforcement Policy Medical Devices Marketed During the...

During the COVID-19 public health emergency, the United States Food and Drug Administration (FDA) has issued hundreds of Emergency Use Authorizations (EUAs) and numerous enforcement policies to facilitate the availability of...more

1/17/2022 / Comment Period , Coronavirus/COVID-19 , Draft Guidance , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Medical Devices , Public Comment , Public Health Emergency

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