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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products."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 The recommendations in this draft guidance are informed by data analysis of general toxicology studies and practices developed during the COVID-19 pandemic to reduce use of non-human primates.
- Document type
- Notice
- Federal Register document number
- 2026-10873
- Published
- Jun 1, 2026
- Action
- Notice of availability.
- Docket
- FDA-2026-D-2839
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on the draft guidance by July 31, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Topics (auto-tagged)
- Vaccines / biologics
Source: Federal Register API, document 2026-10873. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.