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PDUFA VII: FDA, Industry Agree To Set Minimum Carryover Balance Levels

 
• By Derrick Gingery

The minimum total will increase from eight weeks of operating expenses in FY 2023 to 10 weeks by FY 2025.

A minimum carryover balance could affect user fee rates in PDUFA VII.

The prescription drug user fee program is likely to include a minimum carryover balance beginning in fiscal year 2023, as the US Food and Drug Administration and industry attempt to better control the excess revenue collected each year.

New details of the PDUFA VII discussions posted 24 March indicate the FDA will slowly raise the carryover balance floor...

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