November 16, 2023
On November 13 and 14, SNMMI co-hosted a workshop on PET drug manufacturing with the U.S. Food and Drug Administration (FDA) Office of New Drugs, Office of Regulatory Operations, and Division of Regulatory Operations for Specialty Medicine as well as the Medical Imaging & Technology Alliance (MITA) and the Coalition of PET Drug Manufacturers.
The workshop, “Positron Emission Tomography Drugs: Product Quality Regulatory Submissions, Facility Inspections, and Benefit-Risk Considerations,” covered a wide range of issues related to PET drug manufacturing. Stakeholders discussed trends in facility inspections and compliance, lifecycle management of PET drug applications, control and safety issues, and broader trends impacting PET drug regulation such as labeling and electronic submissions.
“Bringing these key groups together was an essential step in developing a joint understanding of trends and challenges,” said SNMMI President Helen Nadel, MD, FRCPC, FSNMMI, “This will help us improve global understanding of regulatory and compliance issues associated with PET drug manufacturing.”
“The FDA workshop provided a unique opportunity for PET manufacturers to engage and network with the FDA and get answers to their questions,” said SNMMI President-Elect Cathy Sue Cutler, PhD, FSNMMI. “By working together, we ensure that the quality and safety of PET radiopharmaceuticals and that patients have access when they need them.”
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About the Society of Nuclear Medicine and Molecular Imaging
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) is an international scientific and medical organization dedicated to advancing nuclear medicine and molecular imaging, vital elements of precision medicine that allow diagnosis and treatment to be tailored to individual patients in order to achieve the best possible outcomes.
SNMMI’s members set the standard for molecular imaging and nuclear medicine practice by creating guidelines, sharing information through journals and meetings and leading advocacy on key issues that affect molecular imaging and therapy research and practice. For more information, visit http://www.snmmi.org.