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Q&A: Allyson Mullen On ‘Uncharted Waters’ Of Breakthrough Pathway

Executive Summary

Hyman, Phelps & McNamara partner Allyson Mullen has helped many manufacturers get breakthrough device designations from the US FDA. In this conversation, she shares her insights on the process, the best way to prepare, and why some designated devices might be slow to make it to shelves.

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