12 mars 2024
info:eu-repo/semantics/openAccess
vroby, « USA – FDA drafts guidance on classification category for biosimilar supplements », ELSIBI, ID : 10.58079/w08c
The US Food and Drug Administration (FDA) just published draft guidance to assist sponsors determine the appropriate supplement category for biosimilar applications and its goals for reviewing them. The guidance also describes the process for submitting supplements. The FDA Draft guidance can be found on its website. More information on RIS.World.