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Getting Ready for FY 2021 PDUFA Program Fees ā āDear Colleagueā Letter Arrives in the Mail
The FDA has sent a āDear Colleagueā letter (here) to NDA holders to get ready for the start of FY 2021 on October 1, when the program fees (previously called āproduct feesā in previous iterations of PDUFA) will be due for each product (up to 5 in each application) marketed by the application holder.Ā The […]