Regulating the use of radioactive drugs in basic research
Regulating the use of radioactive drugs in basic research
- What is the RDRC program?
- What are the qualifications and requirements of RDRC membership?
- How does an RDRC obtain FDA approval?
- What are the responsibilities of the RDRC?
- What information does the RDRC review?
- Federal Regulations (21 CFR 361.1)
- RDRC forms and checklist
- RDRC CDER NextGen Portal for Electronic Submissions
- Guidances for industry
- FDA RDRC presentations
- List of active RDRC sites
- Contact us
What is the RDRC Program?
The Radioactive Drug Research Committee (RDRC) program began when the Food and Drug Administration published a Federal Register notice on July 25, 1975 classifying all radioactive drugs as either new drugs requiring an Investigational New Drug Application (IND) for investigational use (21 CFR 312) or as generally recognized as safe and effective when administered under the conditions specified in the RDRC regulations (21 CFR 361.1). The RDRC program under 21 CFR 361.1 permits basic research using radioactive drugs* in humans without an IND when the drug is administered under the following conditions:
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The research is considered basic science research and is done for the purpose of advancing scientific knowledge. Under § 361.1(a), this type of research is:
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intended to obtain basic information regarding the metabolism (including kinetics, distribution, dosimetry, and localization) of a radioactive drug or regarding human physiology, pathophysiology, or biochemistry,
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**not **intended for immediate therapeutic, diagnostic or similar purposes (e.g. preventive benefit to the study subject from the research), and
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not intended to determine the safety and effectiveness of a radioactive drug in humans.
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The research study is approved by an FDA-approved RDRC based on the following requirements [§ 361.1(b)(1)(iv)]:
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qualified study investigators
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properly licensed medical facility to possess and handle radioactive materials
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appropriate selection and consent of research subjects
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appropriate quality assurance of radioactive drug administered
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sound research protocol design
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reporting of adverse events by the investigator to the RDRC
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approval by an appropriate Institutional Review Board (IRB)
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The pharmacologic dose of the radioactive drug to be administered is known not to cause any clinically detectable pharmacologic effect in humans [§ 361.1(b)(2)].
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The radiation dose to be administered is justified by the quality of the study being undertaken and the importance of the information it seeks to obtain [§ 361.1(b)(1)(iii)] and is within the limits specified in § 361.1(b)(3).
*The term “radioactive drug” is defined in 21 CFR 310.3(n) and includes a “radioactive biological product” as defined in 21 CFR 600.3
RDRC Forms and Checklist
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Search for "RDRC" on FDA Forms page to get
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FDA 2914: Report on Research use of Radioactive Drugs: Membership Summary
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FDA 2915: Report on Research use of Radioactive Drugs: Study Summary
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RDRC Protocol Review Checklist: Criteria for the Evaluation of the Appropriateness of Research Studies Under a RDRC (PDF - 18KB)
RDRC CDER NextGen Portal for Electronic Submissions
For Radioactive Drug Research Committee Electronic Submissions
Guidances for Industry
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RDRC Final Guidance: Human Research without an Investigational New Drug Application (August, 2010) (PDF - 417KB)
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Developing Medical Imaging Drug and Biological Products
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Part 1: Conducting Safety Assessments (PDF - 471KB)
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Part 2: Clinical Indications (PDF - 231KB)
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Part 3: Design, Analysis, and Interpretation of Clinical Studies (PDF - 307KB)
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PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 399KB)
FDA Radioactive Drug Research Committee Program Presentations
- Presentations from 2016 and older are available on the FDA archive
Contact Us
You may email the RDRC Team at RDRC@cder.fda.gov.
Other Resources
- Academy of Molecular Imaging
- American Association of Physicists in Medicine
- American College of Radiology
- American Pharmacists Association
- Conference of Radiation Control Program Directors
- Health Physics Society
- International Commission on Radiological Protection
- Medical Imaging and Drug Development
- Positron Emission Tomography (PET)
- Radiological Society of North America
- Society of Nuclear Medicine