Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products."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 The recommendations in this draft guidance are informed by data analysis of general toxicology studies and practices developed during the COVID-19 pandemic to reduce use of non-human primates.
Abstract as published in the Federal Register.
The comment window is still open until July 31, 2026. This is the point where industry shapes the final rule — submit comments through the Federal Register document below.
The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.