29 min
Jeff Shuren on FDA-sponsor interactions: Where they’ve been and where they’re going Market Pathways
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- Business
Opportunities for companies to engage with FDA during the development and review of new devices have grown over the years. And if Jeff Shuren, Director of the agency’s Center for Devices and Radiological Health, has his way, there will be even more fundamental change in the years to come.
In this conversation, Shuren talks about the evolution of FDA-sponsor interactions that has occurred over his tenure, the “real-time” engagements during COVID-19, and CDRH’s proposal for a TPLC Advisory Program (TAP), which Shuren says will be a game-changer, allowing companies unprecedented access to FDA, payors, providers, and others along the development route.
View the full article: https://bit.ly/2USj8Gi
View the latest issue of Market Pathways: https://bit.ly/2UEqmO9
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
Opportunities for companies to engage with FDA during the development and review of new devices have grown over the years. And if Jeff Shuren, Director of the agency’s Center for Devices and Radiological Health, has his way, there will be even more fundamental change in the years to come.
In this conversation, Shuren talks about the evolution of FDA-sponsor interactions that has occurred over his tenure, the “real-time” engagements during COVID-19, and CDRH’s proposal for a TPLC Advisory Program (TAP), which Shuren says will be a game-changer, allowing companies unprecedented access to FDA, payors, providers, and others along the development route.
View the full article: https://bit.ly/2USj8Gi
View the latest issue of Market Pathways: https://bit.ly/2UEqmO9
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
29 min