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US FDA Sets FY 2021 User Fees, With Coronavirus (Somewhat) In Mind

 
• By Derrick Gingery

ANDA submission rate increases, while the NDA and BLA fee drops and the biosimilar fee is unchanged.

Coronavirus dollar bill
The FDA only mentioned the coronavirus pandemic only in the description of its FY 2021 prescription drug user fee calculations. • Source: Shutterstock

The US Food and Drug Administration announced its fiscal year 2021 user fees, and in many cases sponsors will see discounts compared to FY 2020.

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