Post by Yuma Tsuboi

Three numbers from the FDA after Makary: — ~13½ months: the commissioner's entire formal tenure — 6: CDER directors in a single year — 17: people cycling through the top three posts at CDER, CBER, and the CDC in 18 months And his flagship programs — AI integration, real-time trials, priority vouchers — were mostly never written into rule, so a successor can re-evaluate them in weeks. If your approval-probability model still treats the FDA as a fixed point, you may be modeling the wrong variable. New article on continuity as a variable. #FDA #Pharma #Regulatory #RegulatoryScience #DrugDevelopment #GlobalStrategy #Biotech #MarketAccess