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Session 2: Update on Combination Products Policy Development
Session Chair(s)
John Weiner, JD
Associate Director for Policy, Office of Combination Products, OCPP, OC
FDA, United States
FDA policy regarding regulation of combination products has seen substantial clarification in recent years and its associated processes and practices have seen significant updating to enhance efficiency and consistency. Both PDUFA VI and 21st Century Cures called on FDA to take actions to assess combination products programmatic activities and publish additional guidance. More broadly, FDA has been addressing regulation of products intended for combined use. The Office of Combination Products will give an update on all of these aspects and forecast some future issues we might see addressed in the coming year.
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)
Update on Combination Products Policy Development
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC