FDA Direct: Catching Up on Agency Reforms
Informal roundtable · November 13, 2025
Informal recorded roundtable in which a speaker discussed leadership changes at the FDA’s Centers for Drug Evaluation and Research (Rick Pazdur), regulatory reforms around surrogate endpoints and Bayesian methods, recent oncology product data (zongertinib, dostarlimab, a KRAS inhibitor), cost implications including biosimilars, and recent HRT research findings.
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