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1
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- Mathew L. Thakur, Ph.D.
- President
- Society of Nuclear Medicine
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- Background
- The Society of Nuclear Medicine is an international scientific and
professional organization founded in 1954.
- SNM’s mission is to promote the science, technology and practical
application of nuclear medicine.
- The Society’s 15,000+ members are physicians, technologists, and
scientists specializing in the research and practice of nuclear
medicine.
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- Background (cont)
- In addition to publishing journals, newsletters and books, SNM also
sponsors national and international meetings designed to increase the
competencies of nuclear medicine practitioners and to promote new
advances in the science of nuclear medicine.
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4
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- The SNM supports RDRC, and recognizes RDRC’s contributions to both
nuclear medicine practitioners and the patients they serve.
- SNM welcomes all opportunities to work more closely with FDA staff to
enhance the function and effectiveness of RDRC.
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5
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- SNM believes that RDRC benefits greatly from current 21 CFR 361.1(c) 1
requirements that RDRC be minimally comprised of –
- A nuclear medicine physician
- A person qualified to formulate radioactive drugs
- A person with special competency in radiation safety and radiation
dosimetry.
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6
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- The SNM believes that RDRC would benefit by including a Pharmacologist
in RDRC composition.
- SNM’s rationale for this suggestion is that a Pharmacologist could
better advise RDRC on the invivo interaction of a radiopharmaceutical
or a molecular probe when administered in minute quantities.
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7
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- SNM suggests that;
- At the time of a change of an RDRC member, the RDRC chair submits to
FDA , the suggested new member’s qualifications (CV) and role in RDRC.
- The FDA reviews the qualifications of the proposed RDRC member and
makes recommendations within 30 days.
- RDRC acts on the status of the proposed member.
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Notes