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*OneNexus Program Support Recompete - New Contract

Forecast

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The OneNexus Program is a modernization initiative for the Food and Drug Administration's Center for Drug Evaluation and Research designed to create an integrated drug application review capability. By consolidating previously siloed processes for new drugs, generic drugs, biologics, and drug safety, the program aims to improve information sharing, reduce data redundancy, and streamline regulatory metrics and Congressional reporting. The project leverages the Center for Drug Evaluation and Research Enterprise Informatics Systems to support key legislative mandates such as PDUFA and GDUFA, ensuring the agency can effectively protect public health and safety. The scope of work encompasses business process reengineering, requirements analysis, software configuration, testing, and training to deploy and maintain informatics solutions. Specifically, the program supports the ongoing operations and enhancement of New Drug, Drug Safety, and Generic Workflow Management systems. This forecast for a recompete contract falls under NAICS code 541990 and focuses on enhancing operational efficiency, standardization, and the implementation of innovative automation within the agency's informatics architecture.

General Info

FDA OneNexus program modernizes drug review processes through integrated informatics and system enhancements.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541990 - All Other Professional, Scientific, and Technical Services

Place of Performance

USA

Set-Aside

NONE

Documents

No documents available

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Organization & Contact Information

AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cder Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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.