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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.
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.
On March 13, 2023, FDA issued a notice regarding guidance documents related to the COVID-19 pandemic, including which of the guidance documents will…