Episode Details

Wayne chats with Mike Ryan, Executive Vice President at ELIQUENT and former FDA staffer at CDRH, and Michael Gaba, Food and Drug Vice Chair at Polsinelli. You'll hear their thoughts on where the relationship between FDA and the device industry stands right now; factors that influence how reviewers assess risk, credibility, and readiness during submission reviews; the role of the TPLC approach at CDRH; FDA's elimination of the requirement that RWE submissions include identifiable patient-level information; practical changes sponsors can make to improve regulatory outcomes, without increasing time or cost; and much more.

In our headlines segment, Wayne highlights these major developments: 

Pharma: FDA outlines new "more flexible" approach to CMC requirements for cell and gene therapies

Devices: FDA publishes two final guidance documents clarifying wearable and AI-enabled device oversight

Food: FDA Commissioner Makary chats about new food pyramid on NPR's All Things Considered

Cosmetics: U.S. Rep. Randy Weber introduces PACK Act

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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