
(AGENPARL) – SILVER SPRING gio 11 maggio 2023 The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect fees for biosimilar biological products from October 2017 through September 2022.
Fonte/Source: http://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments