MDUFA

At congressional hearing, FDA's Shuren talks digital health, patient engagement, real-world evidence

By Jonah Comstock 02:51 pm 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...

Digital health innovation was never in question

By Neil Versel 03:31 am November 15, 2012

We've all heard the election post-mortem by now. President Obama's surprisingly comfortable re-election — along with the continued split control of Congress — means that the Patient Protection and Affordable Care Act, a.k.a., Obamacare, is here to stay, although some Republican governors are deciding to let the federal government run their states' health insurance exchanges and are opting out of...