Source: https://www.fda.gov/Drugs/ScienceResearch/ucm574871.htm
Timestamp: 2019-02-24 06:08:27
Document Index: 399029338

Matched Legal Cases: ['§ 361', '§ 361', '§ 361', '§ 361', '§ 361', 'art 1', 'art 2', 'art 3']

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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?
Federal Regulations (21 CFR 361.1)
Guidances for Industry
FDA RDRC Presentations
List of active RDRC sites
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
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)
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
Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting (June 10 to 14, 2016)
Updates from the Division of Medical Imaging Products (DMIP) - Louis Marzella MD, PhD
Expanded Access to Investigational Imaging Drugs - Phillip B. Davis, MD
Extending Imaging Applications to Pediatric Patients - Ira Krefting, MD
PET Drug Inspections and Compliance Update - Krishna Ghosh, MS, PhD
FDA Update - 68Ge - 68Ga Generators and 68Ga radiolabeled Approved Kit - John K. Amartey, PhD
Peptides as Radiopharmaceuticals - CMC Perspectives - Ravindra K. Kasliwal, PhD
Good Analytical Chemistry Practices in PET Radiopharmaceuticals – (poster presentation) - Elise Luong, PhD, Eldon Leutzinger, PhD & Danae Christodoulou, PhD
Presentations from 2015 and older are available on the FDA archive.
You may email the RDRC Team at RDRC@cder.fda.gov.
CAPT (ret.) Richard Fejka, RPh, MS, BCNP, Senior Manager, Radioactive Drug Research Committee Program
Modupe Fagbami, RDRC Regulatory Health Project Manager
Ira Krefting, MD, Deputy Director of Safety, Division of Medical Imaging Products
Page Last Updated: 09/27/2017