Business · 21/06/2024Updated: 10/17/2026 · 1 min read
FDA Releases Final Guidance on Human User Safety in New Animal Drug Applications
Summary
The Food and Drug Administration (FDA) has published a final guidance document (GFI #278) outlining principles for assessing human user safety in new animal drug applications, including new generic animal drugs, to help sponsors prepare for approval or conditional approval.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →