PDUFA VII: Drug application fees increase by 25% in first year of new five-year deal

The FDA un­veiled its user fee rates for pre­scrip­tion drugs, biosim­i­lars, gener­ics and med­ical de­vices last Fri­day — and with the ex­cep­tion of biosim­i­lar ap­pli­cants, spon­sors across the board will have to bud­get more mon­ey for FY24.

For the FDA to re­view ap­pli­ca­tions re­quir­ing clin­i­cal da­ta, spon­sors will have to pay re­view fees of more than $4 mil­lion each, or about a 25% in­crease from FY 2023’s rate, which was about $3.2 mil­lion. The hike comes af­ter the FDA on­ly mod­est­ly in­creased the fees last year, rais­ing them about 4% from FY22 to FY23.

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