MDUFA

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...
By Neil Versel 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...