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.
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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.
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.
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.