PET Community Hosts FDA Workshop

On Friday, February 21, SNMMI, alongside the Food and Drug Administration (FDA), members of the coalition for PET drugs, Medical Imaging Technology Alliance (MITA), and World Molecular Imaging Society (WMIS) hosted a workshop entitled “Pet Drugs: A Workshop on Inspections Management and Regulatory Issues.”

The purpose of this workshop was to provide a forum for the exchange of information and perspectives on the regulatory and compliance framework for Positron Emission Tomography (PET) drug manufacturing. Bringing all stakeholders together will improve the global understanding of regulatory and compliance topics associated with PET drug manufacturing.

You can find both slides and the webinars here.

Goals and Objectives

  • Discuss regulatory compliance for the development and manufacturing of PET drugs and pathways for drug applications, application maintenance, and inspections based on Part 212.
  • Share perspectives from industry, academia, investigators and regulators on inspectional findings and trends.
  • Provide information on the management of Part 212 inspections and maintenance of PET NDAs and ANDAs.

Topics for Discussion

  • Trends on Inspections and Compliance
  • Lifecycle Management of PET Drug Applications
  • Product Quality Assurance
  • Changing Landscape of PET Drugs: Labeling, Electronic Submissions

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