US FDA User Fees Offer Good And Bad News For Sponsors In FY 2020

Prescription drug user fees increase as many generic and biosimilar fees drop, as illustrated in our infographic.

Doctor holding out your piggy bank wanting payment/ Your Savings To Pay Bill, insert coins to it,Stethoscope financial checkup or saving for medical insurance costs money plan fee Lifestyle concept
The new US FDA user fees will go into effect 1 October. • Source: Shutterstock

The US Food and Drug Administration has announced its FY 2020 user fees, which some industry sectors may applaud. Several rates for generics and biosimilars will decrease from current levels, making submission and other charges more affordable. However, the prescription drug user fee program application fees increased as workload volume continues to break records.

Below is a chart of new prescription drug, generic drug, biosimilar, and compounding outsourcer fees. Also shown are interesting data...

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