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

 
• By Elizabeth Orr

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.

Hand holding navigational travel compass to find direction in open waters.
• Source: Shutterstock

What do manufacturers need to know when they consider applying for a breakthrough designation from the US Food and Drug Administration?

According to Hyman, Phelps & McNamara partner Allyson Mullen, factors might include: the kind of data expected at designation request; whether there’s another product in the same space; and, what...

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