real-world evidence

By Jonah Comstock September 15, 2017
One of the biggest promises of mobile health apps and wearables is the sheer amount of data they collect. As that dataset grows, a number of different stakeholders are taking an interest in it, among them patients themselves, doctors, and clinical researchers. The latter is the focus of a new report out today from the Duke-Margolis Center for Health Policy. “Under a collaborative agreement with...
By Jonah Comstock March 31, 2017
The health subcommittee of the House Energy and Commerce committee met this week to question Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, about the medical device user fee amendments (MDUFA). MDUFA is an agreement between the FDA and industry in which the FDA agrees to do certain things in return for industry groups supporting the agency’s work by paying fees...

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