Radioactive Drug Research
Committee (RDRC) Program
What are the Qualifications and Requirements of RDRC Membership?
[§ 361.1(c)(1)]
·
A RDRC must consist
of at least five individuals as follows:
1.
A physician recognized as a specialist in nuclear medicine [§
361.1(c)(1)].
2.
A person qualified by training and experience to formulate
radioactive drugs [§
361.1(c)(1)].
3.
A person with special competence in radiation safety and
radiation dosimetry [§ 361.1(c)(1)].
4.
Individuals qualified in various disciplines pertinent to the field
of nuclear medicine (e.g., radiology, internal medicine, clinical
pathology, hematology, endocrinology, radiation therapy, radiation
physics, radiation biophysics, and radiopharmacy) [§ 361.1(c)(1)].
·
Other
considerations:
1.
Membership must be sufficiently diverse to permit expert
review of technical and scientific aspects of protocols [§
361.1(c)(1)].
2.
FDA encourages the addition of consultants in pertinent
medical disciplines depending on expertise needed to oversee
specific studies (e.g., pediatric specialist)
[§ 361.1(c)(1)].
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Date created: September 20, 2004 |