The Food and Drug Administration’s science-based mission includes receiving, generating and reviewing a wealth of data and products from the vast array of manufacturers and firms that the agency regulates. The need for a customer-friendly, secure-submission platform is paramount to the FDA efficiently performing this mission. In developing the Electronic Submission Gateway Next Generation (ESG NextGen) project, the FDA has taken a transformative leap forward in its submission technology. Focused on increasing capacity while enhancing security and delivering a seamless user experience, ESG NextGen is advancing a modernized data submission process, scaled uniformly for industry partners.
At the heart of ESG NextGen’s mission is the creation of a streamlined submission process by integrating multiple submission gateways into one unified enterprise platform. In the past, submissions were spread across multiple, often siloed systems, leading to inefficiencies and confusion for users. With ESG NextGen, all submissions are consolidated into one platform, streamlining processes while eliminating the need for users to navigate different systems depending on the submission type. This centralization brings several key benefits: better visibility into submission progress, simplified submission management and improved communication with regulated industries.
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ESG NextGen Focuses on Customer Experience
Perhaps one of the most significant advancements ESG NextGen offers is its focus on customer experience. The platform was designed with input from its users, ensuring that it is intuitive, accessible and easy to navigate. The unified help desk provides a single point of contact for all inquiries and support, streamlining customer service and reducing response time.
ESG NextGen also provides a dramatic increase in submission capacity. Whereas older systems could only handle submissions of a few gigabytes in size, ESG NextGen now supports files of up to 1 terabyte. The increased capacity means that researchers, regulated industries and other key partners can submit complex data sets and large files without concerns about hitting size limits, which is essential as submissions become more data-intensive, driven by advances in technology, research and regulatory requirements.
ESG NextGen’s collaborative model has allowed us to tap into the strengths of multiple sectors, ensuring the platform meets the highest standards of security, capacity and user-friendliness. By leveraging innovative solutions and real-world feedback, the FDA’s Office of Digital Transformation has built a system that integrates seamlessly into existing workflows while anticipating future challenges.
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Reducing Technical Debt by Consolidating Legacy Systems
As part of the agency’s IT strategy, ESG NextGen also tackles the issue of legacy system replacement. The older submission gateways were not equipped to handle the increasing complexity and size of modern submissions. By consolidating these outdated systems, ESG NextGen significantly reduces the technical debt that has accumulated over time and propels the agency forward in how it manages a science and data-driven environment.
The consolidation results in better performance and simplifies future maintenance and upgrades, ensuring that ESG NextGen can adapt to evolving needs without the cost of managing outdated infrastructure. By retiring legacy systems, ESG NextGen is creating a more agile, scalable and future-ready submission platform while retiring expensive maintenance projects.
The modernization of the submission process has made it easier and more secure, which can be key when up-to-the-minute information is required to determine a public health risk. In the past, users needed multiple credentials to access different submission gateways, leading to inefficiencies and potential security risks. ESG NextGen introduces a secure, unified ID access management system that provides users with a single set of credentials for all submission-related activities.
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Secure Identity Management Ensures Seamless Access
Security is strengthened by reducing the attack surface, but this also makes the submission process far more user-friendly. By consolidating access control under one system, ESG NextGen ensures that users have seamless, secure access to the tools and resources they need, while adhering to stringent federal security standards.
The FDA is excited about what ESG NextGen represents for digital submissions to the regulatory agency. Through collaborative partnerships, increased capacity, a unified platform, legacy system replacement, secure identity management and a user-centric approach, ESG NextGen is improving the FDA’s submission management process and encouraging the use of smarter data solutions.
