While not identifying specific situations raising potential questions, the FDA commissioner uses his appearance at agency's annual rare disease event to advise regulatory decisions may be revisited as more data becomes available. 

Much of the 4.5% increase proposed would come from proposed new user fees; almost no new budget authority was allocated in President’s FY 2021 budget request.

Promoting innovation, expansion of data use, and patient and consumer empowerment will affect agency work going forward, the FDA Commissioner said in his first all-staff address. Absent from his all-hands memo was drug pricing, opioids, or any other potentially political themes.