Journal article
Proceedings: PET Drugs-A 2023 Workshop on Product Quality, Regulatory Submissions, Facility Inspections, and Benefit-Risk Considerations
The Journal of nuclear medicine (1978), Vol.66(9), pp.1480-1492
09/2025
DOI: 10.2967/jnumed.125.270011
PMCID: PMC12410302
PMID: 40707140
Abstract
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
(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 (
, 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.
Details
- Title: Subtitle
- Proceedings: PET Drugs-A 2023 Workshop on Product Quality, Regulatory Submissions, Facility Inspections, and Benefit-Risk Considerations
- Creators
- Sue Bunning - Coalition of PET Drug Manufacturers, Fredericksburg, TexasDanae Christodoulou - Office of Product Quality Assessment II, Division of Product Quality Assessment IX, Food and Drug Administration, Silver Spring, MarylandJonathan E Cohen - Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Division of Pharmacology-Toxicology for Rare Diseases, Pediatrics, Urologic and Reproductive Medicine Food and Drug Administration, Silver Spring, MarylandCathy S Cutler - Brookhaven National LaboratoryDavid W Dick - University of IowaKrishnakali Ghosh - United States Food and Drug AdministrationChristopher Ignace - Nusano Inc., West Valley City, UtahRavindra K Kasliwal - Office of Product Quality Assessment II, Division of Product Quality Assessment IX, Food and Drug Administration, Silver Spring, MarylandHsiaoju Lee - University of PennsylvaniaLibero Marzella - United States Food and Drug AdministrationTim Pohlhaus - Guidance (United Kingdom)Peter J H Scott - University of MichiganSally W Schwarz - Washington University in St. LouisIrum A Syed - DRT Strategies Inc., Arlington, VirginiaHenry F VanBrocklin - University of California SystemLaura R Wasil - United States Food and Drug AdministrationSteven S Zigler - Siemens PETNET Solutions, Knoxville, Tennessee
- Resource Type
- Journal article
- Publication Details
- The Journal of nuclear medicine (1978), Vol.66(9), pp.1480-1492
- DOI
- 10.2967/jnumed.125.270011
- PMID
- 40707140
- PMCID
- PMC12410302
- NLM abbreviation
- J Nucl Med
- ISSN
- 1535-5667
- eISSN
- 1535-5667
- Publisher
- Society of Nuclear Medicine and Molecular Imaging
- Grant note
- Coalition of PET Drug ManufacturersMITASNMMIFDA
We thank the Coalition of PET Drug Manufacturers, MITA, the SNMMI, and the FDA for sponsoring and organizing the 2023 workshop, as well as all of the speakers (named in the agenda provided in the supplemental materials) who generously contributed their time and expertise to the program. We also thank Charles Metzger (executive director of the Coalition of PET Drug Manufacturers) and Frank Lutterodt (FDA) for their valuable assistance with this article.
- Language
- English
- Electronic publication date
- 07/24/2025
- Date published
- 09/2025
- Academic Unit
- Radiology; Pharmaceutical Sciences and Experimental Therapeutics
- Record Identifier
- 9984865434202771
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