Where Is the Value in Breakthrough Designation?
The true impact of Breakthrough Device designation may not actually be from working more closely with FDA. Experts from Parexel/Health Advances discuss a quantitative analysis and the experiences of several device companies with the Breakthrough process, highlighting benefits beyond a smoother regulatory path. By Trisha Eustaquio, Paraxel and Darcy Krzynowek and Russ Rapaport, Health Advances.
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