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...
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