The Therapeutics Clinical Working Group has been charged to prioritize and accelerate clinical evaluation of a long list of therapeutic candidates for COVID-19 with near-term potential. The goals have been to prioritize and test potential therapeutic agents for COVID-19 that have already been in ...
At the time of the workshop, FDA expected to release the final version of the guidance soon. Mansfield reviewed a few key pieces of the policy. First, the policy defines an IVD companion device as “an in vitro diagnostic device that provides information that is essential for the safe and ...