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# Oncology Radiopharm. Nonclinical Studies Guidance
- URL: https://www.fdaweb.com/oncology-radiopharm-nonclinical-studies-guidance/
- Published: 2018-06-28T12:00:00.000Z
- Updated: 2026-09-15T00:16:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141788

FDA has issued a draft guidance, *Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations*, to help sponsors design an appropriate nonclinical program for development of radiopharmaceuticals to treat cancer and to give recommendations for certain aspects of product labeling. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM612037.pdf?ref=fdaweb.com) defines a therapeutic radiopharmaceutical as a product that contains a radionuclide and is used in patients with cancer to treat the disease or for palliation of tumor-related symptoms.

Recommendations in the guidance are applicable to products that are administered systemically and undergo alpha, beta, and/or gamma decay. The recommendations generally apply to new products with no previous clinical experience.

The guidance discusses evaluation of toxicities from the ligand; evaluation of radiation toxicities; and information for product labeling as related to reproductive toxicity, genotoxicity, carcinogenicity, contraception, and use in lactating women.

The document is not applicable to oncology therapeutic radiopharmaceuticals with a local route of administration and in general is not applicable to external beam radiation therapy, radiolabeled vaccine products, diagnostic radiopharmaceuticals, or radioactive drugs for research.