Description
The purpose of this guidance is to provide information to assist sponsors in the design of an appropriate nonclinical program for the development of radiopharmaceuticals to treat cancer — also known as oncology therapeutic radiopharmaceuticals — and to provide recommendations for certain aspects of product labeling. For the purpose of this guidance, a therapeutic radiopharmaceutical is a product that contains a radionuclide and is used in patients with cancer to treat the disease or palliate tumor-related symptoms (e.g., pain). Recommendations in this guidance are applicable to products that are administered systemically and undergo alpha, beta, and/or gamma decay.
Scope & Applicability
Product Classes
1Subject of the guidance document
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
3RBE value used for estimating equivalent dose of alpha-emitting radiopharmaceuticals.
Dose limits for tissue reactions in radiation protection
Used to calculate the required period of contraception and breastfeeding cessation.
Identified Hazards
Hazards
1toxic effects resulting from radiation exposure
Related CFR Sections (2)
- 21CFR361.1§ 361.1 Radioactive drugs for certain research uses.
(a) Radioactive drugs (as defined in § 310.3(n) of this chapter ) are generally recognized as safe and effective when administered, under the conditions set forth in paragraph (b) of this section, to human research subjects during the course of a research project intended to obtain basic informationRead full regulation →
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
See Also (8)
- Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations: Guidance for Industry (Status: Final)
- Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND: Guidance for Clinical Investigators, Sponsors, and IRBs (Status: Final)
- Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs (Status: Final)
- PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide (Status: Final)
- Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (Status: Final)
- PET Drug Products - Current Good Manufacturing Practice (CGMP) (Status: Final)
- Exploratory IND Studies: Guidance for Industry, Investigators, and Reviewers (Status: Final)