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Leveraging New Meeting Opportunities in PDUFA VII: Experiences with Type D and INTERACT
Session Chair(s)
Victoria Dohnal, RAC
Director, Regulatory Policy, North America
Johnson & Johnson, United States
This forum will address experience to date with new meeting types included in PDUFA VII, including Type D and INTERACT. Forum participants will evaluate successes, opportunities for improvement, and discuss how learnings can be shared.
Learning Objective : Evaluate experiences to date with Type D and INTERACT meetings included in PDUFA VII; Identify opportunities to improve implementation of new meeting types to promote innovation and optimize FDA-Sponsor Interactions.
Speaker(s)
Industry Update
Victoria Dohnal, RAC
Johnson & Johnson, United States
Director, Regulatory Policy, North America
FDA Update
Christy L. Cottrell
FDA, United States
Chief, Project Management Staff, ORO, DRO-OD, CDER
FDA Update
Adriane Fisher, MBA, MPH
FDA, United States
Regulatory Project Manager, OTP, CBER
Industry Update
Alex May, MS
Genentech, United States
Regulatory Policy and Advocacy
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