Zdrowie i gospodarka · 14/09/2017

FDA Announces Biosimilar User Fee Rates for Fiscal Year 2018

The US Food and Drug Administration (FDA) has set the fees for biosimilar biological products for the fiscal year 2018, following the Biosimilar User Fee Amendments of 2017 (BsUFA II). The fees will be in effect from October 1, 2017, to September 30, 2018.