Description
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.
Scope & Applicability
Product Classes
3Guidance focuses on dosage optimization for RPTs in oncology.
Subject of the guidance document
Contrasted with modern targeted oncology drugs
Stakeholders
2Entity responsible for submitting applications under section 524B
Assist sponsors in the nonclinical evaluation
Regulatory Context
Attributes
5Refers to the radiation dose of the radiopharmaceutical.
Refers to the recommended interval between administrations and number of cycles.
DLT period of one cycle
estimated organ absorbed doses should be accompanied by estimated uncertainties
better define RPT-specific organ tolerances
Identified Hazards
Hazards
1rAESI monitored for at least 5 years
Related CFR Sections (2)
- 21CFR310.3§ 310.3 Definitions and interpretations.
As used in this part:Read full regulation →
- 21CFR312.23§ 312.23 IND content and format.
(a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:Read full regulation →
See Also (8)
- Chapter 48 7348.809A Radioactive Drug Research Committee (Status: Final)
- Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies (Status: Final)
- Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications (Status: Final)
- Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments (Status: Final)
- Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (Status: Final)
- Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry (Status: Final)
- Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry (Status: Final)
- Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers: Guidance for Industry (Status: Final)