FDA releases draft guidance on streamlined nonclinical safety studies for monoclonal antibodies
In December 2025, FDA released draft guidance for industry titled “Monoclonal Antibodies: Streamlined Nonclinical Safety Studies.” The draft guidance provides recommendations for streamlined approaches to assess long-term safety for monospecific antibodies, or monoclonal antibodies that recognize a single molecular target. The draft guidance also describes scenarios for which general toxicology studies are not warranted or may be limited to a short-term study and addresses reproductive, developmental, and juvenile toxicity assessments. When finalized, the guidance is intended to assist sponsors in avoiding the unnecessary use of animals, supporting the principles of reducing, refining, and replacing the use of animals for pharmaceutical development. FDA will accept comments on the draft guidance until February 2, 2026.