FDA Streamlines Safety Testing for Monoclonal Antibodies
December 09, 2025
December 09, 2025
WASHINGTON, Dec. 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has announced the availability of a draft guidance that offers recommendations for streamlined nonclinical safety studies for certain drug development products.
The guidance entitled "Monoclonal Antibodies: Streamlined Nonclinical Safety Studies" focuses on monospecific antibodies, which are products that recognize a single molecular target.
The document . . .
The guidance entitled "Monoclonal Antibodies: Streamlined Nonclinical Safety Studies" focuses on monospecific antibodies, which are products that recognize a single molecular target.
The document . . .