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Oncology ‘Beyond Breakthrough’ Takes Shape: FDA Project Will Create Benefits ‘Menu,’ Rescission Process

 
• By Kate Rawson

US FDA’s oncology team has come to realize that a better understanding of how to personalize its ‘all-hands-on-deck’ approach would be even more helpful – especially for first-time sponsors.

Health care success medical research breakthrough and medicine discovery as a doctor stethoscope shaped as a stethoscope breaking a wall to a target as a cure metaphor with 3D illustration elements.
While there is much to like about the program, FDA wants to move away from the idea that Breakthrough is somehow a pre-market “seal of approval” from the agency. • Source: Shutterstock

The US Food & Drug Administration’s ongoing review of the Breakthrough Therapies program will identify best practices from the nearly 10-year-old expedited program and identify ways to make the designation more meaningful to sponsors – including a “menu” of the types of meetings and communications available once the designation has been granted.

Oncology officials acknowledge that the often-used “all hands on deck” description of Breakthrough is “somewhat vague,” and that a better explanation and outline of the available benefits is needed, Office...

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