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FDA Guidance for Industry: Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations

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.

 

Posted on the FDA website on 1 August 2019

2019-08-08T19:44:17+00:0008.08.2019|Regulatory Affairs, Training|