PDUFA First: Fees To Support Device Center Staff
To enhance combination product reviews, drug fee revenue will pay for related positions in CDRH.
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The Center for Biologics Evaluation and Research may need more fee revenue to add employees to handle the increasing cell and gene therapy workload.
FY 2018 is first year that US FDA's device center got PDUFA funding for staffers; our infographic shows how CDER is getting an increasing proportion of user fee staff even as other sections of the agency have seen growth over the last five years.
Discussion draft includes US FDA negotiated user fee amounts well short of the total in recent Trump budget outline.