Issue Date: August 19, 2025
Issued by: Oncology Center of Excellence
Topic(s): Clinical – Medical
Status: Draft
Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development: Draft Guidance for Industry
This guidance is intended to assist sponsors in identifying an optimized dosage(s) (administered activity and schedule) for radiopharmaceutical therapies (RPTs) for oncology indications during clinical development and prior to submitting a marketing application for a new indication and usage.This guidance should be considered along with the FDA guidance Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases (August 2024). Some of the recommendations outlined in that guidance may be applicable to RPTs; however, this guidance is more specific to RPTs.This guidance does not address selection of the initial RPT administered activity in first-in-human trials nor does it address other aspects of the clinical development of RPTs, for example, use of dosimetry software, use of fixed administered activity dosing for a population versus dosing determined by personalized dosimetry, and theranostic co-development.
Download the Guidance Document
