FDA's Revival of US Early Feasibility Studies; Can Industry Keep Up?
Episode description
In this panel discussion from our virtual Dublin Innovation Summit Conference 2021 experts dive deep on FDA’s recent revival of early feasibility studies in the US. The initial findings from an MDIC working group indicate that FDA’s efforts to promote early feasibility studies appear to be working to increase both the number and efficiency of these trials in the US, demonstrating that, at least on occasion, regulators can be ahead of industry. Now the burden is on device companies to follow suit.
Panelists:
Andrew Glass, CEO, Vivasure Medical
Chip Hance, CEO, Regatta Medical
Jaime Walkowiak, General Counsel, Instil Bio
Aaron V. Kaplan, M.D., Chairman and CMO, Conformal Medical
Moderator: Stephen Levin, Editor-In-Chief, Market Pathways
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About Market Pathways
Your premium guide to global medical device regulation, reimbursement and policy. Market Pathways delivers incomparable intelligence exploring the people, challenges, and opportunities impacting the global medtech regulatory and reimbursement community. View the latest issue of Market Pathways on MyStrategist.com