Episode Details

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