Business · 26/07/1999
FDA Releases Draft Guidance on Monoclonal Antibody Products Under Orphan Drug Regulations
The Food and Drug Administration (FDA) has released a draft document outlining its criteria for determining the sameness of monoclonal antibody products under the Orphan Drug Act and implementing regulations, aimed at providing clarity for sponsors and manufacturers.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →