CDISC Membership

The contract involves the renewal of the FDA’s membership in the CDISC standard organization, which is essential for maintaining and advancing the data standards used in the FDA's clinical and non-clinical review processes. CDISC serves as the foundational framework that allows the FDA to modernize regulatory procedures effectively and maintain its leadership role in global health regulatory standards. The renewal represents a small annual investment that supports the FDA’s active participation in CDISC discussions and the development of these crucial standards. The contract is a forecasted opportunity managed by the Food and Drug Administration under NAICS code 813920. It does not specify an exact solicitation number or set-aside status, and details about the place of performance are not provided. Points of contact include the CDER Acquisition Liaison and a contracting officer whose identity is yet to be determined. This membership renewal ensures the FDA can sustain its role as a key player internationally in establishing and adhering to critical regulatory data standards.