FDA Workshop Agenda and Reports on Positron Emission Tomography (PET) Drug Manufacturing

https://www.fda.gov/drugs/pet-drugs-workshop-inspections-management-and-regulatory-considerations-02212020-02212020#event-information

Summary

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 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

Meeting Agenda, Presentations, Webcasts and Event Materials