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)].

Page Last Updated: 04/06/2016
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