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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

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

Registration

Please register online on the Eventbrite website.

Visiting the FDA Campus

Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map. 

Food and Drink

Public meeting attendees may bring their own food and drink. However, the FDA cannot guarantee the use of a refrigerator or microwave. Light refreshments and sandwiches are often available for purchase at public meetings. Restaurants near the FDA White Oak campus are available, before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening.

Virtual Attendance Information

This meeting will be hybrid. The Zoom link will be provided to all registered attendees before the meeting. 

Accessibility

The FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email ONDPublicMTGSupport@fda.hhs.gov at least 7 days before a public meeting. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities.

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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