Back to Agenda
Session 1: Updates and Insights from the Office of Combination Products (OCP)
Session Chair(s)
James Wabby, MHS
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
AbbVie, United States
This session will explore updates and priorities in FDA policy regarding regulation of combination products. There has been substantial clarification in recent years and its associated processes and practices have seen significant updates in enhancing 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 aspects, current inspection trends, warning letters, and forecast some future issues we might see addressed in the coming year.
Learning Objective : - Recognize updates and priorities in FDA policy
- Define combination product and identify steps taken for uncertainty of approval
- Interpret the RFD process: comparing binding/non-binding
- Analyze and evaluate warning letters and inspections from a training perspective for the combination product lifecycle
- Recognize current topics the FDA is observing, what industry should continue to do, and what is causing challenging circumstances
Speaker(s)
Updates and Insights from the Office of Combination Products (OCP)
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC
Panelist
Thinh X. Nguyen
FDA, United States
Director, Office of Combination Products, OCPP
Panelist
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC
Have an account?