Virtual FDA-Industry MDUFA Negotiations To Kick Off After Months Of Delay
The US FDA and industry stakeholders are set to finally start monthly user fee negotiations online by February. The process has already been significantly delayed due to the pandemic and recent holidays.
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US FDA commissioner Stephen Hahn argued on 27 October that his device center should consider more user-fee investments to alleviate the agency’s workload and address new innovations – but industry wants the FDA to finish hiring and work with what’s there.
During the first round of user fee negotiations, industry questioned FDA's estimated cost of $750 million needed to continue the device user fee program between 2018 and 2022. Lobby groups for the device industry continue to emphasize user fees should supplement congressional appropriations to pay for FDA's review of devices.
The document from the Medical Device Innovation Consortium aggregates external data sources, various statistical methods and lays out other considerations for sponsors to help speed up and bolster a premarket product application to the US FDA.