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FDA Roundup: December 22, 2023

FDA Roundup: December 22, 2023
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Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for E

Guidance for Industry ....

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A Regulator Looks Back On What We Learned From Accelerated SARS-CoV-2 Neutralizing mAbs Development

Prior knowledge, platforms, parallel backup programs, and strategic timing all come into play when rapidly scaling up a mAbs development program in. ....

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FDA Announces The Discontinuation Of Certain COVID-19-Related Guidance Documents - Operational Impacts and Strategy

In the wake of the Department of Health and Human Services' (HHS) February announcement that they will be discontinuing the COVID-19 public health emergency (PHE) declaration on May 11, 2023. ....

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The Long (Un)Winding Road: FDA Maps Out How The End Of The Public Health Emergency Will Impact Its COVID-19 Policies - Operational Impacts and Strategy

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. ....

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