At the late November 2023 AFDO/RAPS Combination Products Summit, held in Fort Worth, Texas, the new Office of Combination Products (OCP) Director James Bertram, and Assistant Director John (Barr) Weiner gave a joint opening address on OCP’s strategic priorities and actions. Bertram began with updates on the OCP team and points of contact. Weiner then reviewed the progression over the past 30 years in FDA’s CP regulation and the strategies and opportunities for moving forward at FDA and internationally. Bertram concluded with updates on FY 2022 combination product data and OCP’s current and upcoming activities.