Monoclonal Antibodies: Streamlined Nonclinical Safety Studies | FDA

Docket Number: FDA-2025-D-4634 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Monoclonal Antibodies: Streamlined Nonclinical Safety Studies.” The draft guidance provides recommendations for streamlined approaches to assess long-term safety from monoclonal antibodies that recognize a single molecular target (referred to as monospecific antibodies); describes when 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 unnecessary use of animals, particularly non-human primates (NHPs), in furtherance of the 3R principles of reducing, refining, and replacing the use of animal testing. Submit Comments Submit Comments Online You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written comments to: Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 All written comments should be identified with this document's docket number: FDA-2025-D-4634.