Carryover Conundrum: FDA, Industry Tussle Over Unspent MDUFA Funds

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A dispute over how FDA is spending user fee “carryover” funds is fueling discord during ongoing MDUFA V reauthorization talks.

Having more money in the bank than budgeted seems like a good situation to be in, but in the case of the FDA device use fee program, leftover funds are stoking controversy between industry and the agency.

Device industry groups complain FDA has not been transparent about its plans for spending higher-than-usual user fee “carryover” balances—fees that remain unspent and unobligated at the end of a fiscal year—to revamp its IT systems. They say the issue is casting a shadow over ongoing MDUFA V reauthorization talks.


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