Business Talk

Keeping track of FDA’s user fee program performance

It has been 9 months since the passage of legislation reauthorizing four of the user fee programs, the FDA User Fee Reauthorization Act of 2023. But during that time, how has the FDA been doing at meeting its obligations for PDUFA, MDUFA, GDUFA, BsUFA and OMUFA? In this AgencyIQ feature, we look at all of the agency’s user fee commitments and determine which have meet successfully met.

AgencyIQ’s analysis of how the FDA is doing.

As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

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