Insights on Evidence and Communication with FDA in Device Submissions

Wayne chats with Mark DuVal, CEO of DuVal & Associate; Bryan Feldhaus, President of DuVal & Associates; and Chris Lyle, Vice President of Evidence Strategy at DuVal & Associates. You'll hear their thoughts on what's happening right now at FDA and in the medical device industry; whether companies should engage FDA early in the pre-submission process or make their case in the actual submission; common breakdowns in the submission process; the importance of real-world evidence and where companies can still fall short; holding FDA to a consistent standard after initial feedback; and much more.

In our headlines segment, Wayne highlights these major developments:

Pharma: FDA reports progress after first year of roadmap to reduce animal testing in drug development

Devices: CDRH issues letter to combination product manufacturers with information on potential nitrosamine impurities

Food: FDA issues warning letters to food companies following serious violations

Cosmetics: FDA releases Grand Rounds presentation recording featuring experts from Office of Cosmetics and Colors

In our Resource Links segment, we list key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net.

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Music by Dvir Silver from Pixabay.