Radioactive Drug Research
Committee (RDRC) Program
How Does an RDRC Obtain FDA
Approval?
[§ 361.1(c)(4)]
Submit an Application
1.
Complete
FDA 2914 (Word) including:
-
the names and qualifications of the RDRC members and
consultants
[§ 361.1(c)(4)]
-
a statement that the RDRC agrees to comply with the
requirements set forth in § 361.1. [§ 361.1(c)(4)]
2.
We recommend that you attached a current curriculum vitae (CV)
(dated) for each RDRC member and consultant. Each CV should include
the specific qualifications and experience that meet the
requirements of membership (see What
are the Qualifications and Requirements of RDRC Membership?)
3.
Submit the completed application form and CVs to the
following address:
Food and Drug Administration
Center for Drug Evaluation and Research
Division of Medical Imaging and Radiopharmaceutical Drug Products
(HFD-160)
5600 Fishers
Lane, Room 18B-45
Rockville, MD
20857
Attention: RDRC (CAPT Richard Fejka)
Approval by FDA
1.
FDA will review the RDRC application and, if acceptable, issue an
approval letter to the RDRC chairperson.
Approval is
based upon a positive assessment of the qualifications of the
members of the RDRC and the assurance that all necessary fields of
expertise are covered [§ 361.1(c)(4)] (see
What are the
Qualifications and Requirements of RDRC Membership?).
2.
A RDRC must obtain FDA approval before it may approve
research studies under 21 CFR 361.1 [§ 361.1(b)(1)].
Approval of a
RDRC will remain in effect unless and until FDA withdraws such
approval. Approval of a RDRC may be withdrawn at any time for
failure of the RDRC to comply with the requirements of § 361.1 [§
361.1(c)(4)].
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Date created: September 20, 2004, updated May 25, 2006 |