Tagged as: PDUFA

FDA Announces Biosimilar User Fee Rates for FY 2017

The FDA has announced the rates for biosimilar user fees for the 2017 Fiscal Year: FY17 BsUFA Fees Biological Product Development Initial $203,810 Annual $203,810 Application w/Clinical Data $2,038,100 w/o Clinical Data $1,019,050 Supplement w/Clinical Data $1,019,050 Product $97,750 Establishment $512,200 Reactivation $407,620 The biosimilar user fees for a given fiscal year…

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