Business · 29/03/2001Updated: 10/17/2026 · 1 min read
FDA Releases Guidance for Industry on Monoclonal Antibodies Used in Drug Manufacturing
Summary
The FDA has published a guidance document outlining recommendations for drug manufacturers on how to properly include information about monoclonal antibodies in their applications, particularly for new drugs and biologics.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →