Drugs

Monoclonal Antibody Streamlined Safety Study Guidance

FDA has published a draft guidance, Monoclonal Antibodies: Streamlined Nonclinical Safety Studies, to assist sponsors in implementing streamlined approaches for nonclinical safety assessments of monoclonal antibodies that recognize a singular molecular target, referred to as monospecific antibodies. The document says it is intended to facilitate drug development for monospecific antibodies while avoiding unnecessary use of animals, particularly nonhuman primates, consistent with the principles of reducing, refining, and replacing animal testing.

“By reducing animal testing and incorporating an integrated knowledge-based risk assessment, this guidance is anticipated to facilitate greater efficiencies in product development,” it says.

The guidance’s streamlined approaches are intended to apply broadly to the development programs for monospecific antibodies in any indication except those reviewed by the Office of Oncologic Diseases, which provides flexibility through oncology-specific guidances, FDA says.

The document does not address toxicology studies related to multispecific antibodies, conjugated antibodies, or antibody constructs.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome