MITA Concludes Joint Workshop on PET Drug Regulations with FDA, SNMMI and Coalition of PET Drug Manufacturers

Nov 15, 2023, 15:04 PM

Washington, D.C. – The Medical Imaging & Technology Alliance (MITA) –  the leading organization and collective voice of medical imaging and radiopharmaceutical manufacturers, innovators, and product developers – has recently held a Positron Emission Tomography Drugs: Product Quality Regulatory Submissions, Facility Inspections, and Benefit-Risk Considerations event co-hosted with the U.S. Food and Drug Administration’s (FDA) Office of New Drugs (OND), Office of Regulatory Operations (ORO), and Division of Regulatory Operations for Specialty Medicine (DRO-SM), as well as the Society of Nuclear Medicine & Molecular Imaging (SNMMI) and the Coalition of PET Drug Manufacturers.

“Manufacturing and distributing PET drugs is wholly unique, so the MITA PET group is extremely pleased to have the opportunity to bring these stakeholders together for a thorough discussion,” said Sue Bunning, Managing Director of Positron Emission Tomography for MITA. “Not only did this event provide a forum for bringing better understanding to PET drug regulations, but it also allowed for nuanced consideration of problems and possible solutions.”

The event, held on November 13 and 14, covered a wide range of issues related to Positron Emission Tomography (PET) drug manufacturing. Stakeholders discussed regulation considerations for facility inspections and compliance, product quality considerations and regulatory applications, control and safety issues and risk management as well as broader trends impacting PET drug regulation.

The MITA PET Group represents 20 companies that research, innovate and bring new radiopharmaceutical diagnostics and therapies through the FDA as well as those on the frontlines of developing and delivering just-in-time manufactured PET drug doses to patients.