Radioactive Drug Research Committee (RDRC) Program

· Other considerations:

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)].

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FDA/Center for Drug Evaluation and Research

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)].

Date created: September 20, 2004