WASHINGTON, June 1 -- Food and Drug Administration has issued a notice called: Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on June 1 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products." When finalized, this guidance will assist sponsors in implementing streamlined approaches for general toxicology, for nonclin...