USFDA GDUFA FY 2015 User Fee Rates for Biosimilars, Prescription Drug User Fees, Drug Establishments and Re-inspection..

In addition to the FY 2015 GDUFA user fee rates, FDA also announced the rates for biosimilar user fees, prescription drug user fees, and the establishment and re-inspection fees related to human drug compounding outsourcing facilities that elect to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)...