What are the Qualifications and Requirements of RDRC Membership?

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)

Source