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Location

FDA White Oak Campus
The Great Room
Conference Center
10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States

Co-Sponsors

• Society of Nuclear Medicine and Molecular Imaging
• Coalition of PET Drug Manufacturers
• Medical Imaging & Technology Alliance

Summary

This public workshop will be hosted by the Office of New Drugs (OND), Office of Regulatory Operations (ORO), and Division of Regulatory Operations for Specialty Medicine (DRO-SM). The purpose of this workshop is 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.

Goals and Objectives 

• Discuss regulatory compliance for the development and manufacturing of PET drugs and pathways for regulatory applications. 
• 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

Meeting Agenda

• Agenda (PDF - 188 KB)

Zoom Webinar

• Day 1-Monday Morning | Duration: 4h 38m 50s
• Day 1-Monday Afternoon | Duration: 3h 39m 08s
• Day 2-Tuesday Morning Q&A | Duration: 3h 32m 09s

Contact

For additional details and questions contact the FDA’s CDER/OND/Public Meeting Support Team at ONDPublicMTGSupport@fda.hhs.gov. 

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