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A “Breakthrough” Reality Check: Sponsors Seek FDA Flexibility On Manufacturing, Diagnostics
This article highlights a panel discussion on the state of FDA’s Breakthrough Therapy designation, moderated by Catalyst President Nancy Bradish Myers, during the DIA annual meeting. Panelists represented both industry (Pharmacyclics, Genentech) and patient advocacy (Friends of Cancer Research) perspectives on FDA’s implementation of the Breakthrough provisions in the FDA Safety and Innovation Act of