FDA: Oncology Radiopharmaceutical Labeling Must Include Genotoxicity

June 29, 2018

Labeling for oncology radiopharmaceuticals must include information on the potential for genotoxicity and adverse reproductive toxicity, the FDA said in new draft guidance.

The draft covers aspects of labeling and nonclinical studies, including animal biodistribution and dosimetry, pharmacology, first-in-human dose selection and toxicology. 

The agency defines a therapeutic radiopharmaceutical as any product that contains a radionuclide and is used in patients with cancer for treatment of the disease or for palliation of tumor-related symptoms such as pain.

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