US nonclinical test design guidance:
This article was originally published in Clinica
Executive Summary
The US FDA has issued a draft guidance on how to design nonclinical tests to determine the potential risk of radiation-induced injuries months or even years after a patient undergoes radiation therapy for cancer or other conditions. The guidance is not intended for diagnostic radiopharmaceuticals or for radiobiologicals, a June 20 Federal Register notice pointed out. Comments are due by September 19.