Abstract
Recent advances in the development of new molecular imaging agents for positron emission tomography (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 ten years. However, the continued use of PET drugs for diagnostic imaging procedures is reliant upon a sustainable network of PET manufacturing facilities operating in accordance with the current good manufacturing practice (cGMP) regulations for PET drugs (21 CFR 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 co-sponsored 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 members of academic and commercial PET manufacturers as well as representatives from the FDA. The co-authors on this paper are all members of the workshop organizing committee.
- Quality Assurance
- Radiochemistry
- Radiopharmaceuticals
- 21CFR212
- PET drug manufacture
- Regulatory oversight
- current Good Manufacturing Practice
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