Experts at AMCP Nexus say biosimilar launches should prompt payers to revisit step therapy and measure value beyond market share.
News|Articles|May 13, 2026
5 Key Regulatory Shifts From Makary's Era at the FDA
Author(s)Pearl Steinzor
Fact checked by: Laura Joszt, MA
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.
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The FDA has undergone a series of major policy shifts under Marty Makary, MD, MPH, who recently
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