MDUFA Meeting Postponed Again Due To COVID-19, This Time Indefinitely
The COVID-19 crisis had already forced the US FDA to postpone its first public meeting on the medical device user-fee negotiations to early next May, which was to be webcast. Now the agency has postponed the meeting indefinitely.
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For the second time in the past few months the US agency has rescheduled a webcast of a public meeting meant to start MDUFA V user-fee negotiations.
The US FDA has bumped up the cost of filing for a premarket application in fiscal year 2021 by roughly 7%. That’s slightly higher than the user fee increases under MDUFA IV last year.
The largest medical device lobby group will host its annual conference online instead of in person. The meeting that had been set to occur over three days in Toronto will now take place in September and end in October.