As US FDA recovers from aducanumab and looks towards an advisory committee on Pfizer’s COVID vaccine, it’s worth reflecting on how Office of Vaccine Research & Review Director Marion Gruber created positive turning points for the agency during a general discussion of vaccine approval standards at the VRBPAC.
The senior US FDA official at an advisory committee meeting can choose to adopt very different tactics in how they engage in the discussion, depending on the situation.
Sometimes, an office director may sit back and say nothing during an eight-hour meeting and limit their interaction to passing...