The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products."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 nonclinical safety assessments of certain oncology pharmaceuticals. The guidance is intended to facilitate drug development for biological products and conjugated products for the treatment of cancer while avoiding unnecessary animal use. The recommendations in this draft guidance are informed by data analysis of general toxicology studies and practices developed during the COVID-19 pandemic to reduce use of non-human primates.
US Federal Register - FDA Guidance Notices · June 01, 2026
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry
Original title: Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability
FDA draft guidance on streamlined nonclinical toxicology study approaches for oncology biologics and conjugated products to reduce animal use.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.