*OneNexus Program Support Recompete - New Contract

The OneNexus Program is creating and implementing a modern, efficient and integrated drug application review capability for the FDA's Center for Drug Evaluation and Research (CDER). This project focuses on Nexus use case implementation across the Center. Prior to this project, the drug application review processes development efforts were siloed across different projects focusing on new drugs, generic drugs and biologics, and drug safety and separate office. The project improves information sharing, facilitates collecting regulatory metrics and Congressional reporting, reduces redundant data and processes, and mitigates the need for costly modifications on legacy systems. The objective of this project is to modernize informatics solutions that directly and indirectly support key legislation that drives CDER's mission (e.g., PDUFA, GDUFA, etc.) leveraging existing capabilities that form the basis of CDER's Enterprise Informatics Systems (CEIS) and components of CDER's informatics system architecture. The project leads business process analysis and reengineering, requirements analysis, software configuration, testing, training, etc. to ensure the delivery of solutions that meet system users' needs and support CDER's mission. The project will implement, enhance, and maintain informatics systems that improve operational efficiency, standardization, and knowledge management, while facilitating development of innovative automation solutions. Ultimately this will help maintain and advance CDER's global leadership, improve CDER's ability to meet legislative mandates, and allow the center to better protect the health and safety of the American public. The project will support ongoing operations and enhancements of existing informatics solutions as well as the deployment of new implementations in the CEIS environment. This project includes New Drug WFM, Drug Safety WFM and Gen WFM.