With Congressional Deadline Looming, FDA And Industry Schedule MDUFA Meeting
The US regulatory agency has scheduled a 3 February meeting to continue negotiating a MDUFA deal with medtech representatives. Meanwhile, top lawmakers have set a 9 February deadline to be briefed on the matter.
You may also be interested in...
The US FDA and industry have scheduled five meetings over the next two weeks to negotiate a device user fee deal. Both sides are under pressure from lawmakers to come to an agreement.
Sen. Patty Murray said she doesn’t want more uncertainty about user fees during the COVID-19 pandemic and will move to get all the user fees renewed before they expire in September.
The US agency and the medtech industry still have significant disagreements, which means they will miss a 15 January deadline to send the MDUFA V user-fee deal to Congress. Insiders disagree, however, on how severe those disagreements are and when a deal can be reached.