FDA Released a Draft Guidance Document Titled "Monoclonal Antibodies: Streamlined Nonclinical Safety Studies."

On December 2, 2025, the U.S. FDA released a draft guidance document titled "Monoclonal Antibodies: Streamlined Nonclinical Safety Studies."   This document systematically outlines a simplified pathway for nonclinical safety studies of monoclonal antibody drugs for the first time, with the most notable change being the reduction of nonhuman primate use. In some cases, longterm animal toxicity studies of more than three months may no longer be necessary.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/monoclonal-antibodies-streamlined-nonclinical-safety-studies