Radioactive Drug Research Committee (RDRC) Program

• 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

• Guidances for Industry

• Historical Information for RDRC Program

• FDA RDRC Presentations and Publications

• 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:

• 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:
  • 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, 
  • not intended for immediate therapeutic, diagnostic or similar purposes (e.g. preventive benefit to the study subject from the research), and
  • not intended to determine the safety and effectiveness of a radioactive drug in humans.
• The research study is approved by an FDA-approved RDRC based on the following requirements [§ 361.1(b)(1)(iv)]:

  • qualified study investigators

  • properly licensed medical facility to possess and handle radioactive materials

  • appropriate selection and consent of research subjects

  • appropriate quality assurance of radioactive drug administered

  • sound research protocol design

  • reporting of adverse events by the investigator to the RDRC

  • approval by an appropriate Institutional Review Board (IRB)

• 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)].
• 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.
 

Federal Regulation (21 CFR 361.1 Radioactive drugs for certain research uses.)

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1
 

RDRC Forms and Checklist

• FDA 2914 (PDF - 747KB) Report on Research use of Radioactive Drugs: Membership Summary
• FDA 2915 (PDF - 2MB) Report on Research use of Radioactive Drugs: Study Summary
• RDRC Protocol Review Checklist: Criteria for the Evaluation of the Appropriateness of Research Studies Under a RDRC (PDF - 22KB)
   

Guidances for Industry

• RDRC Final Guidance: Human Research without an Investigational New Drug Application (PDF - 417KB) (August, 2010)
• Developing Medical Imaging Drug and Biological Products
  • Part 1: Conducting Safety Assessments (PDF - 471KB)
  • Part 2: Clinical Indications (PDF - 231KB)
  • Part 3: Design, Analysis, and Interpretation of Clinical Studies (PDF - 307KB)
• PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 399KB)
   

FDA Radioactive Drug Research Committee Program Presentations and Publications 

Presentations

• Society of Nuclear Medicine Annual Meeting (June 9-13, 2012)
  
  • Update on Radioactive Drug Research Committees and RDRC Inspections , Richard Fejka, MS, RPh, BCNP, FAPhA (PDF - 681KB)
  • Radiation Dose: What do we want?, Orhan Suleiman, MS, PhD, FAAPM (PDF - 755KB)
  • Radiation Dose Safety Issues, Orhan Suleiman, MS, PhD, FAAPM (PDF - 1MB)
  • Adverse Event Reporting: Clinical Investigator Responsibilities, Ira Krefting, MD (PDF - 324KB)
  • Using an IND in Clinical Research, Lucie Yang, MD, PhD (PDF -  2MB)
  • Drug Development Overview, Lucie Yang, MD, PhD (PDF - 227KB)
  • New Drug Approvals FDA: Year in Review, Lucie Yang, MD, PhD (PDF - 323KB)
  • FDA Advisory Committees, Lucie Yang, MD, PhD (PDF - 757KB)
  • CMC Issues in Radiopharmaceutical INDs, Ravindra Kasliwal, PhD (PDF - 103KB)
  • Regulation of PET Drugs & CGMP, Ravindra Kasliwal, PhD (PDF - 567KB)
  • Transitioning from Microdose Exploratory IND to Traditional IND: Division of Medical Imaging Products Perspectives, Siham Biade, PharmD, PhD (PDF - 162KB)
  • Clinical Trial Efficacy Endpoints for Molecular Imaging Products Development , Qi Feng, MD, PhD (PDF - 147KB)

  • PET Drug Inspections and Current Good Manufacturing Practices for PET Drugs, Brenda Uratani, PhD (PDF - 362KB)

• Society of Nuclear Medicine Annual Meeting (June 5-9, 2010)
  
  • Update on the Radioactive Drug Research Committees (PDF - 177KB), Richard Fejka, MS, RPh, BCNP
  • Technical Problems in Imaging Based Trials (PDF - 2MB), Orhan Suleiman, MS, PhD, FAAPM

Publications

• The Radioactive Drug Research Committee: Background and Retrospective Study of Reported Research Data (1975–2004) (PDF - 161KB)
   

Contact Us

You may email the RDRC Team at RDRC@cder.fda.gov.

• Captain Richard Fejka, RPh, MS, BCNP, Senior Manager, Radioactive Drug Research Committee Program
• Orhan Suleiman, MS, PhD, Senior Science Advisor
• Ira Krefting, MD, Deputy Director of Safety, Division of Medical Imaging Products