FDA Doc Bemoans ‘Dearth’ Of Pediatric Devices, Says Real-World Data Could ‘Make A Difference’
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.
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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.
FDA Debuts ‘Collaborative Communities’ With NESTcc, Optic Imaging Groups
The US agency is participating in collaborative communities centered around eye health and the development of real-world evidence, representing the first two of what the agency hopes will be at least 10 communities by the end of 2020.
Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?