 |
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Draft Guidance for Industry,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.)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1
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
Back to Top 
Back to Regulatory Information
Date created: September 20, 2004, updated November 21, 2005 |
|
