The Food & Drug Administration (FDA) is overhauling its Electronic Submission Gateway (ESG) with the development of ESG NextGen. This initiative is being recognized for representing a significant advancement in the agency's digital capabilities and is a result of close collaboration between the FDA Office of Digital Transformation (ODT), various FDA Centers, and industry partners. The current ESG has been in place for more than 15 years and, while initially adopted by only a few FDA Centers, has since become the primary channel for electronic submissions across the agency.

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The modernization effort for ESG NextGen is notable for its emphasis on both technological innovation and stakeholder engagement. The project team has not only focused on creating a state-of-the-art, scalable, and secure technical solution but also worked diligently to involve FDA Centers and industry stakeholders in the process. This collaborative approach is uncommon in government projects and is key to the success of the modernization.

From the outset, the ESG NextGen team understood the importance of integrating feedback from both FDA Centers and industry. To this end, they developed a comprehensive communication strategy to ensure all parties were informed, involved, and had the opportunity to contribute. This involved multiple rounds of engagement, including over 40 meetings with FDA Centers and more than 13 sessions with industry stakeholders, involving thousands of participants globally.

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The feedback received during these interactions has significantly influenced the project's direction. For example, initial plans to discontinue certain legacy functions were revised based on industry input, highlighting the project's responsiveness to stakeholder needs. This approach not only fosters better relationships with industry but also ensures that the ESG NextGen will effectively meet current and future needs.

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As the modernization progresses into the User Acceptance Testing (UAT) phase, both industry volunteers and FDA Centers will actively participate in testing to validate the system’s performance and reliability. This extensive involvement is crucial for ensuring a smooth transition from the old system to ESG NextGen.

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Overall, the ESG NextGen modernization exemplifies the FDA’s commitment to innovation and collaboration, setting a high standard for future development efforts. The project's success in breaking down organizational barriers and incorporating diverse feedback deserves recognition, such as the Citizens Award for Using Innovation, Data, and Breaking Down Organizational Barriers.