FDA Meeting Will Focus On Aggregating Patient-Generated Health Data
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.
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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.
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.
FDA Will Keep Listening To Patient-Engagement Experts
The US agency says in a 6 January Federal Register notice that it’s keeping its Patient Engagement Advisory Committee in place through October 2021 so it can gather more patient feedback that will come in handy when regulatory decisions need to be made. The committee, formed after the agency made a cultural shift to consider patient input on the types of products it allows on the market, was supposed to expire October 2019.