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FDA User Fees to Rise and Fall as New Fee Agreements Move Forward

August 20, 2021


Biopharmaceutical companies will pay more than $3 million to file an application seeking FDA approval of a new drug application (NDA) or biologics license application (BLA) during fiscal year 2022. This record charge to evaluate new drugs and biologics reflects agency analysis of additional personnel and resources needed to process its growing workload. The annual program fee paid by each manufacturer with marketed prescription drugs holds fairly even at about $370,000. And while the actual increase in the application fee is not that much, passing the $3 million mark has drawn attention and further concern about FDA’s overdependence on revenue from regulated industry.

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