MDUFA Negotiations Go Into Overdrive
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.
You may also be interested in...
Pop The Champagne: Medtech Industry, FDA Reach MDUFA V User-Fee Deal
The deal includes a $110m Total Product Lifecycle Advisory Program pushed for by the US agency, but also credits unused funds past a certain threshold back to industry.
Industry Looks To Califf’s Leadership As It Negotiates User Fee Deal, Fights Pandemic
After the US Senate barely greenlit Robert Califf to again helm the US FDA, industry sources say they look forward to him taking an active role in ensuring the next user fee deal is successful.
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.