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Session 8: FDA Panel
Session Chair(s)
John Weiner, JD
Associate Director for Policy, Office of Combination Products, OCPP, OC
FDA, United States
Points of contact for combination product issues at the Medical Product Centers and Office of Combination Products will discuss priorities and challenges for combination products, share experiences from product-specific activities, and offer advice for how best to engage the Agency to ensure a smooth, efficient process.
Learning Objective : At the conclusion of this session, participants should be able to:- Utilize Agency processes to support engagement with combination product applicants
- Describe how best to seek Agency feedback on regulatory issues for combination products
- Explain FDA internal procedures and processes that affect timing and methods for interacting with sponsors
Speaker(s)
Panelist
Kristina Lauritsen, PhD
FDA, United States
Combination Products Regulatory Policy Advisor, OEP, CDER
Panelist
James P. Bertram, PhD, MS, RAC
FDA, United States
Director, Office of Combination Products, OC
Panelist
Sheryl L. Lard Whiteford, PhD
FDA, United States
Associate Director for Quality Assurance, OCD, CBER
Panelist
Melissa Burns, MS
FDA, United States
Senior Program Manager, Office of Combination Products, OCPP, OC