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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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• Source: Alamy

The US Food and Drug Administration and medtech industry representatives are scheduled to meet five times over the next two weeks to negotiate the Medical Device User Fee Amendment (MDUFA V) deal. The back-to-back meetings come after lawmakers expressed disappointment at the lack of an agreement and have asked to be briefed on the issue.

According to a source with knowledge of the negotiations, the regulatory agency has scheduled the meetings with AdvaMed, the Medical Device Manufacturers Association, and the Medical Imaging and Technology Alliance...

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