FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: MONOCLONAL ANTIBODIES: STREAMLINED NONCLINICAL SAFETY STUDIES; DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Dec. 3 -- Food and Drug Administration has issued a notice called: Monoclonal Antibodies: Streamlined Nonclinical Safety Studies; Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on Dec. 3 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Monoclonal Antibodies: Streamlined Nonclinical Safety Studies." The draft guidance provides recommendations for streamlined approaches to assess long-term safety from monoclonal antibodies that recognize a single molecular target (referred to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); de...