SNM meeting to examine FDA PET radiotracer development requirements

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SNM and the International Partnership for Critical Markers of Disease (CMOD) are co-hosting a meeting on Friday, May 1 at the Natcher Auditorium, National Institutes of Health, Bethesda, Md., to evaluate the FDA's requirements for manufacturing PET radiopharmaceuticals.

This meeting will take place immediately following SNM's Multimodality Cardiovascular Molecular Imaging Symposium (CVMI), held April 30-May 1 in Bethesda.

"We are pleased to collaborate with the International Partnership for Critical Markers of Disease on this important meeting," said Michael Graham, MD, PhD, SNM president-elect and director of nuclear medicine at the University of Iowa Carver College of Medicine. "New developments in molecular imaging technologies are dramatically improving the ways in which cardiovascular disease, neurological disorders and cancer are diagnosed and treated. It is essential that we work together as a scientific community to facilitate personalized medicine through the development of advanced imaging techniques and new radiopharmaceuticals that will enable physicians to determine early on the precise location of disease, and evaluate and monitor the effectiveness of therapy."

Industry representatives from companies such as GE Healthcare as well as the FDA's medical imaging division and SNM will survey the regulation history of PET and review current regulations for PET compounding and will address the critical necessity of developing new tracers and radiopharmaceuticals in compliance with FDA's current good manufacturing practice (CGMP) and chemistry, manufacturing and control (CMC) regulations.

Experts also plan to address the need for harmonization and standardization across multiple imaging sites and discuss the concept of a centralized IND and SNM's new Clinical Trials Network. The meeting will conclude with an interactive question and answer session and panel discussion, according to SNM.