TY - JOUR
T1 - Proceedings
T2 - PET Drugs-A Workshop on Inspections Management and Regulatory Considerations
AU - Coalition of Drug Manufacturers
AU - Bunning, Sue
AU - Ignace, Christopher
AU - Mattmuller, Steve
AU - Schwarz, Sally W.
AU - Scott, Peter J.H.
AU - VanBrocklin, Henry F.
AU - Zigler, Steven S.
N1 - Publisher Copyright:
© 2022 by the Society of Nuclear Medicine and Molecular Imaging.
PY - 2022/7/1
Y1 - 2022/7/1
N2 - Recent advances in the development of new molecular imaging agents for PET have led to the approval of several new molecular entities for PET imaging by the U.S. Food and Drug Administration (FDA) within the last 10 y. However, the continued use of PET drugs for diagnostic imaging procedures is reliant on a sustainable network of PET manufacturing facilities operating in accordance with the regulations for current good manufacturing practices for PET drugs (title 21, Code of Federal Regulations, part 212). With this goal in mind, a public workshop entitled "PET Drugs: A Workshop on Inspections Management and Regulatory Considerations" was held on the FDA campus in Silver Spring, MD, on February 21, 2020. The workshop was cosponsored by the FDA's Center for Drug Evaluation and Research, the Society of Nuclear Medicine and Molecular Imaging, the Medical Imaging Technology Alliance, and the World Molecular Imaging Society, in collaboration with the Coalition of PET Drug Manufacturers. The organizing committee for the workshop consisted of representatives from academic and commercial PET manufacturers as well as FDA staff members. The coauthors on this paper are all members of the workshop-organizing committee.
AB - Recent advances in the development of new molecular imaging agents for PET have led to the approval of several new molecular entities for PET imaging by the U.S. Food and Drug Administration (FDA) within the last 10 y. However, the continued use of PET drugs for diagnostic imaging procedures is reliant on a sustainable network of PET manufacturing facilities operating in accordance with the regulations for current good manufacturing practices for PET drugs (title 21, Code of Federal Regulations, part 212). With this goal in mind, a public workshop entitled "PET Drugs: A Workshop on Inspections Management and Regulatory Considerations" was held on the FDA campus in Silver Spring, MD, on February 21, 2020. The workshop was cosponsored by the FDA's Center for Drug Evaluation and Research, the Society of Nuclear Medicine and Molecular Imaging, the Medical Imaging Technology Alliance, and the World Molecular Imaging Society, in collaboration with the Coalition of PET Drug Manufacturers. The organizing committee for the workshop consisted of representatives from academic and commercial PET manufacturers as well as FDA staff members. The coauthors on this paper are all members of the workshop-organizing committee.
KW - 21 CFR §212
KW - PET drug manufacture
KW - quality assurance
KW - radiochemistry
KW - radiopharmaceuticals
KW - regulatory oversight
UR - http://www.scopus.com/inward/record.url?scp=85133980827&partnerID=8YFLogxK
U2 - 10.2967/jnumed.121.263443
DO - 10.2967/jnumed.121.263443
M3 - Article
C2 - 35058318
AN - SCOPUS:85133980827
SN - 0161-5505
VL - 63
SP - 1117
EP - 1123
JO - Journal of nuclear medicine : official publication, Society of Nuclear Medicine
JF - Journal of nuclear medicine : official publication, Society of Nuclear Medicine
IS - 7
ER -