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MICHBIO: MDS 2025—Close the Gap: Evidence Strategies for FDA & Payer Success

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Join us at Grand Valley State University, L.V. Eberhard Center in Grand Rapids on Thursday, September 25 at the premier event for Michigan’s medical device community.

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FEATURED SESSION

Evidence Development Challenges Posed

by FDA and Payers

Most regulatory strategies focus on achieving approval or clearance. But too often, lack of concordance between sponsors and FDA in the Q-submission process can complicate, extend, and imperil regulatory reviews. Subsequently, widespread payer coverage routinely lags product approval – often for years. This presentation will show you how to tailor a comprehensive evidence plan to address the needs of both stakeholders to help shorten the gap. 

Mark DuVal

CEO

DuVal & Associates

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