Proceedings: PET Drugs-A 2023 Workshop on Product Quality, Regulatory Submissions, Facility Inspections, and...

Advances in PET radiopharmaceutical technologies necessitate continued dialogue between members of the PET drug manufacturing community and the U.S. Food and Drug Administration (FDA) to ensure that these drugs continue to be safe and effective and are sustainably supplied in accordance with regulatory commitments and current good manufacturing practice (cGMP) regulations. After the success of the 2020 PET drugs workshop, the FDA hosted a follow-up public workshop entitled "PET: Product Quality, Regulatory Submissions, Facility Inspections, and Benefit-Risk Considerations." The 2023 workshop addressed knowledge gaps that emerged during the 2020 workshop and themes from responses to a survey of PET drug manufacturers. The goal of this workshop was to support continued communication between the FDA and PET stakeholders to drive clarity toward PET cGMP regulations described in the Code of Federal Regulations (title 21, part 212) and PET Drug cGMP guidance documents, with the objective to improve compliance with PET drug manufacturing guidelines. In addition, investigational PET drugs (Code of Federal Regulations, title 21, part 312) were discussed, as they are intimately connected with the approval process and eventual cGMP manufacturing regulations once they matriculate to clinical use. The workshop was held on November 13-14, 2023, on the FDA campus in Silver Spring, MD. The Society of Nuclear Medicine and Molecular Imaging, the Medical Imaging and Technology Alliance, and the Coalition of PET Drug Manufacturers cosponsored the workshop with the FDA. This article summarizes the discussions that were conveyed at this workshop.