Use of 55 PET Radiotracers Under Approval of a Radioactive Drug Research Committee (RDRC) Isaac M
Jackson et al. EJNMMI Radiopharmacy and Chemistry (2020) 5:24 EJNMMI Radiopharmacy https://doi.org/10.1186/s41181-020-00110-z and Chemistry GUIDELINE ARTICLE Open Access Use of 55 PET radiotracers under approval of a Radioactive Drug Research Committee (RDRC) Isaac M. Jackson1,2, So Jeong Lee1,3, Alexandra R. Sowa1, Melissa E. Rodnick1, Laura Bruton1, Mara Clark1, Sean Preshlock1, Jill Rothley1, Virginia E. Rogers1, Leslie E. Botti1, Bradford D. Henderson1, Brian G. Hockley1, Jovany Torres1, David M. Raffel1, Allen F. Brooks1, Kirk A. Frey1, Michael R. Kilbourn1, Robert A. Koeppe1, Xia Shao1 and Peter J. H. Scott1* * Correspondence: pjhscott@med. umich.edu Abstract This article is dedicated to Capt. Richard Fejka, MS, RPh, BCNP, Background: In the US, EU and elsewhere, basic clinical research studies with USPHS (Ret.) on the occasion of his positron emission tomography (PET) radiotracers that are generally recognized as retirement after 39 years of safe and effective (GRASE) can often be conducted under institutional approval. For government service and 17 years overseeing the RDRC Program at example, in the United States, such research is conducted under the oversight of a the U.S. Food and Drug Radioactive Drug Research Committee (RDRC) as long as certain requirements are Administration. met. Firstly, the research must be for basic science and cannot be intended for 1Department of Radiology, University of Michigan, 2276 immediate therapeutic or diagnostic purposes, or to determine the safety and Medical Science Bldg I, SPC 5610, effectiveness of the PET radiotracer. Secondly, the PET radiotracer must be generally Ann Arbor, MI 48109, USA recognized as safe and effective.
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