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# Draft Guide on Oncology Therapeutic Radiopharmaceuticals
- URL: https://www.fdaweb.com/draft-guide-on-oncology-therapeutic-radiopharmaceuticals/
- Published: 2018-06-29T12:00:00.000Z
- Updated: 2026-09-15T00:16:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141801

*Federal Register* notice: FDA has made available a draft guidance entitled “Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.” The document discusses how to design appropriate nonclinical studies before beginning first-in-human trials and through product approval. In addition, it provides recommendations for product labeling, such as duration of contraception to minimize potential risk to a developing embryo/fetus and recommendations for lactating women to minimize potential risk to a nursing infant. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-06-29/pdf/2018-14055.pdf?ref=fdaweb.com).