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The FDA has issued new draft Q&A guidance (available here) on Forms FDA 3542a and FDA 3542, providing additional clarity on Orange Book...

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On Friday December 11, 2020, the FDA granted Emergency Use Authorization (“EUA”) of the Pfizer-BioNtech COVID-19 vaccine.  Approval of...

To address the COVID-19 public health crisis, FDA issued two immediately in effect guidance documents:  FDA Guidance for Industry (April...

The Secretary of the Department of Health and Human Services issued a declaration1 providing liability immunity to certain individuals...