Business · 06/10/2021Updated: 10/17/2026 · 1 min read

FDA Releases Guidance on Biomarkers and Surrogate Endpoints for New Animal Drugs

The Food and Drug Administration (FDA) has released a final guidance document (GFI #267) outlining its approach to using biomarkers and surrogate endpoints in clinical trials for new animal drugs, in line with the Federal Food, Drug, and Cosmetic Act (FD&C Act).