Top FDA Officials Tout Use Of Real-World Evidence Based On New Report
The report looks at a broad range of submission and product types and concludes use of RWE/RWD has helped get new products to market faster.
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The topic is central to the Patient Engagement Advisory Committee, which recently got its tenure extended. It also fits into the FDA’s thinking on real-world evidence and total product lifecycle approach.
The document from the Medical Device Innovation Consortium aggregates external data sources, various statistical methods and lays out other considerations for sponsors to help speed up and bolster a premarket product application to the US FDA.
CDRH’s Shuren Talks MDUFA, Industry’s Premarket Wants, Emerging Technologies, And More In Wide-Ranging Interview
In an exclusive interview with Medtech Insight, FDA device center director Jeff Shuren said the agency will possibly discuss issues such as postmarket surveillance and patient engagement in upcoming MDUFA negotiations. He also talked about some recent big wins for the agency and his vision for the coming year.