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 2012. The discussion included an exploration of FDA’s intent to provide some flexibility in incorporating certain companion diagnostics into the Breakthrough program, and the need for companies to address manufacturing issues related to Breakthrough products early on, to ensure that chemistry, manufacturing and controls (CMC) issues do not delay availability of Breakthrough-designated products.

A “Breakthrough” Reality Check: Sponsors Seek FDA Flexibility On Manufacturing, Diagnostics
The Pink Sheet

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