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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Vasum Peiris, an MD and the US agency’s chief medical officer for pediatrics and special populations, is worried about the lack of innovative devices for young people. But he’s hopeful that real-world evidence could turn that around.
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.