ARC Initiatives Ongoing

The ARC process has proven successful over time, leading to 20 completed projects up to 2022 and 15 ongoing projects at the beginning of 2023. The process of setting up an ARC Initiative starts by identifying the topic in need of standardization by Academic Thought Leaders. The ARC Governance Charter defines further steps needed to present the proposed Initiative to the ARC Board which is charged with assessing feasibility, timing, bandwidth, and priority for the topic. Importantly, the perspectives of the FDA Liaison to the ARC Board are critical in the process. In this section we present approved and ongoing ARC Initiatives.