News|Articles|May 13, 2026

5 Key Regulatory Shifts From Makary's Era at the FDA

From rewriting drug approval standards to embedding AI in review workflows, former FDA commissioner Marty Makary, MD reshaped how evidence, speed, and access are balanced in US drug regulation.

The FDA has undergone a series of major policy shifts under Marty Makary, MD, MPH, who recently resigned from his position as FDA commissioner.¹ These shifts reflect an agenda centered on accelerating drug development, modernizing review systems, and recalibrating evidentiary standards.