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Criteria to be met by members of Radioactive Drug Research Committees
Reference: 21 CFR 361.1(c)(1)
A Radioactive Drug Research Committee (RDRC) must consist of at least five individuals
- A physician recognized as a specialist in nuclear medicine [§ 361.1(c)(1)].
- A person qualified by training and experience to formulate radioactive drugs [§ 361.1(c)(1)].
- A person with special competence in radiation safety and radiation dosimetry [§ 361.1(c)(1)].
- 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…
Criteria to be met by members of Radioactive Drug Research Committees
Reference: 21 CFR 361.1(c)(1)
A Radioactive Drug Research Committee (RDRC) must consist of at least five individuals
- A physician recognized as a specialist in nuclear medicine [§ 361.1(c)(1)].
- A person qualified by training and experience to formulate radioactive drugs [§ 361.1(c)(1)].
- A person with special competence in radiation safety and radiation dosimetry [§ 361.1(c)(1)].
- 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
- Membership must be sufficiently diverse to permit expert review of technical and scientific aspects of protocols [§ 361.1(c)(1)].
- 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)].