GUIDANCE DOCUMENT
Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry August 2019
- Docket Number:
- FDA-2018-D-1772
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and Research
The purpose of this guidance is to provide information to assist sponsors in the design of an appropriate nonclinical program for the development of radiopharmaceuticals to treat cancer — also known as oncology therapeutic radiopharmaceuticals — and to provide recommendations for certain aspects of product labeling. For the purpose of this guidance, a therapeutic radiopharmaceutical is a product that contains a radionuclide and is used in patients with cancer to treat the disease or palliate tumor-related symptoms (e.g., pain). Recommendations in this guidance are applicable to products that are administered systemically and undergo alpha, beta, and/or gamma decay.
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Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2018-D-1772.