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Session 1: FDA Update
Session Chair(s)
John Weiner, JD
Associate Director for Policy, Office of Combination Products, OCPP, OC
FDA, United States
FDA regulation of combination products has seen huge advances in recent years. Both PDUFA VI and 21st Century Cures have included programmatic changes for combination products, and FDA has been busy issuing guidances and regulations as well as implementing organizational changes to aid in the review of combination products. The Office of Combination Products will give an update on all of these aspects and forecast some future issues we might see addressed under the new FDA Commissioner.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe recent regulatory changes for combination products
- Identify the top policy priorities for FDA’s Office of Combination Products
- Discuss recently issued guidances and regulations as well as internal FDA changes affecting combination products
Speaker(s)
FDA Update
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC