1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development Draft Guidance for Industry August 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2025-D-1757
Issued by:
Guidance Issuing Office
Oncology Center of Excellence

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.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2025-D-1757.

Back to Top