The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency previously set forth in...more
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
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