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# Final Guide on Oncology Radiopharm. Drug Studies
- URL: https://www.fdaweb.com/final-guide-on-oncology-radiopharm-drug-studies/
- Published: 2019-08-01T12:00:00.000Z
- Updated: 2026-09-15T01:41:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144669

FDA has published a final guidance, *Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations*, to give sponsors information on the design of an appropriate nonclinical program for developing radiopharmaceuticals to treat cancer, also known as oncology therapeutic radiopharmaceuticals. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-therapeutic-radiopharmaceuticals-nonclinical-studies-and-labeling-recommendations-guidance?ref=fdaweb.com) also contains recommendations for certain aspects of product labeling.

The guidance is specific to therapeutic radiopharmaceuticals for oncology indications and covers topics not addressed in current FDA or International Council for Harmonization guidances, such as nonclinical studies in support of first-in-human trials and approval. It provides additional information that supplements an 11/2011 guidance on the design of late radiation toxicity studies.

The guidance recommendations generally apply to new products with no previous clinical experience. Concepts discussed are 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.

Contents are Introduction, Background, Pharmacology, Animal Biodistribution and Dosimetry, Toxicology, First-in-Human Dose Selection, Labeling Recommendations, Glossary, and References.