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Office of Oncology Drug Products

Radioactive Drug Research Committee (RDRC) Program 

FDA opens a second comment period for the November 16, 2004 Public Meeting due to the release of the Draft Guidance for Industry, Investigators, and Reviewers: Exploratory INDs.

  May 10, 2005


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 not known 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.)


RDRC Forms and Checklist

Guidances for Industry

  • Developing Medical Imaging Drug and Biological Products
    • Part 1: Conducting Safety Assessments [Word] or [PDF]
    • Part 2: Clinical Indications [Word] or [PDF]
    • Part 3: Design, Analysis, and Interpretation of Clinical Studies [Word] or [PDF]
  • PET Drug Products - Current Good Manufacturing Practice (CGMP) [HTML] or [Word] or [PDF]

Other Resources

Contact Us

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

  • Division of Medical Imaging and Hematology Products  

  • CAPT Richard Fejka, MS, BCNP, USPHS, Nuclear Pharmacist

  •  Office of Oncology Drug Products
  • Orhan Suleiman, MS, PhD, FAAPM, Senior Science Policy Advisor

  • vacant, Project Management Officer

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Date created: September 20, 2004, updated November 21, 2005

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