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)].
Radioactive Drug Research Committee (RDRC) Program
-
Content current as of:
12/03/2025
-
Regulated Product(s)
Topic(s)
