Radiopharmaceuticals: FDA Finalizes Guidance on Nonclinical Studies, Labeling
The US Food and Drug Administration (FDA) on Thursday finalized guidance on designing nonclinical studies and product labeling for radiopharmaceuticals used in oncology.FDA says the guidance is meant to provide a “more consistent approach in nonclinical studies and product labeling” for a “unique and challenging area of product development.”
In the guidance, FDA defines therapeutic radiopharmaceuticals for oncology as products that contain a radionuclide that are used to treat cancer or alleviate tumor-related symptoms. FDA notes that the guidance does not apply to therapeutic radiopharmaceuticals that are administered locally, as the nonclinical study designs described in the guidance may not apply.
Specifically, the 13-page guidance is intended to help sponsors design nonclinical studies ahead of first-in-human (FIH) trials and throughout pre-approval product development. The guidance also provides recommendations for labeling issues specific to radiopharmaceuticals, such as potential adverse reactions related to genotoxicity, reproductive toxicity, carcinogenicity as well as recommendations for women who are lactating to avoid exposing infants to radiation.
The final guidance comes roughly a year after the agency released the draft version for comment and is largely unchanged from the draft document, with some edits made for clarity.
Guidance, Federal Register Notice