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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…
The COVID-19 pandemic presented the U.S. Food and Drug Administration (FDA or Agency) with a monumental task of shifting its operations and the way it approached the regulation of...
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...
The coming end to the COVID-19 public health emergency doesn’t mean the end of all FDA authorities exercised during the pandemic. Our FDA/Food, Drug & Device Team explores what will...