2025-21864: Monoclonal Antibodies: Streamlined Nonclinical Safety Studies; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Monoclonal Antibodies: Streamlined Nonclinical Safety Studies." The draft guidance provides recommendations for streamlined approaches to assess long-term safety from monoclonal antibodies that recognize a single molecular target (referred to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.
The agency’s own summary, as published.
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