4 June 2020 - Even before the pandemic, the FDA was having trouble estimating its resource needs for biosimilar application reviews. An ongoing process may fix that.

Coronavirus disease 2019 (COVID-19) put a crimp in just about everything, including the FDA’s new drug and biosimilars review activities. 

In so doing, the pandemic helped make the case for an FDA project to upgrade its system for assessing workplace capacity and setting user fees required from manufacturers that make drug application submissions.

Read Center for Biosimilars article