Proceedings: PET Drugs-A Workshop on Inspections Management and Regulatory Considerations

Coalition of Drug Manufacturers

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)1117-1123
Number of pages7
JournalJournal of nuclear medicine : official publication, Society of Nuclear Medicine
Volume63
Issue number7
DOIs
StatePublished - Jul 1 2022

Keywords

  • 21 CFR §212
  • PET drug manufacture
  • quality assurance
  • radiochemistry
  • radiopharmaceuticals
  • regulatory oversight

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