BIOBASED PRODUCTS BLOG

FDA DHHS Announces 2021 Biosimilar User Fee Rates
Posted on August 07, 2020 by Lynn L Bergeson

By Lynn L. Bergeson 

On August 4, 2020, the U.S. Food and Drug Administration (FDA) Department of Health and Human Services (DHHS) announced the rates for biosimilar user fees for fiscal year (FY) 2021. The fees assessed are used by FDA for certain activities in connection with biosimilar biological product development, review of applications for approval of biosimilar biological products, and approval of product applications. The established fees will apply from October 1, 2020, through September 30, 2021.

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