Intake and Data Exchange (CDER Event Data Management 8.0)

The Food and Drug Administration is forecasting the expansion of its Event Data Management capability under the Intake and Data Exchange (CDER Event Data Management 8.0) initiative to support additional use cases and deliver a more integrated submissions and data management solution. This effort aims to enhance the existing system by broadening its functionality to accommodate broader data exchange needs across regulatory operations, improving efficiency and coordination in handling event-related information. The project is aligned with NAICS code 541519, indicating it involves other scientific and technical consulting services, and is intended to modernize and scale the current infrastructure to meet evolving regulatory data demands. The opportunity is currently in the forecasting phase with a posted date of May 25, 2026, and no solicitation number assigned yet. The point of contact for program inquiries is the Cder Acquisition Liaison at cderacquisitions@fda.hhs.gov, while the contracting officer role remains to be determined. There is no specific place of performance or set-aside type indicated, and no details are provided regarding geographic restrictions or small business preferences. Potential vendors should prepare for a future full solicitation that will likely require proven experience in managing complex regulatory data systems and delivering scalable, integrated solutions for government health agencies.