Question: Am I able to use my current submission packaging process?

Answer: Sponsors can continue to use eSubmitter or other existing methods to package their submissions for upload to ESG NextGen.

Question: Will I be able to continue using AS2 for submitting?

Answer: ESG NextGen will provide an API method to facilitate system-to-system file submissions.

Question: How soon will the ESG NextGen be available for Industry testing?

Answer: As seen on the Timeline page, Q2/Q3 of FY24 will be the Industry’s opportunity to test their submissions on ESG NextGen. FDA will publish a more definitive timeline for testing in the coming months.

Question: What kind of authentication and certifications will be required before writing to the API?

Answer: FDA plans to use Client ID and Secret key for API authentication and OAuth for API authorization. Both are widely used approaches for API security. Users will need to login to the ESG Unified Submission Portal and/or use the API to register and obtain API Client ID and Secret key before using APIs.

Question: Does the Agency anticipate any changes in the transmission of xml files or tar.gz files?

Answer: No, FDA does not anticipate any changes in the transmission of said files.

Question: Will the ESG NextGen API follow current Internet standards that can be implemented by current vendors, like AS2 does?

Answer: The APIs will be built using the RESTful standard. FDA will publish API specifications for industry review close to the time of the demo (July).

Question: In recognizing that the ESG NextGen will enable new functionalities and employ an API, could the Agency provide details on any direct impact to users that users need to be aware of (e.g., updates/changes to digital certificates and credentials)?

7.A. Answer: FDA plans to provide APIs for variety of tasks in ESG NextGen, including initial and subsequent submissions, status inquiries, and other service functions to facilitate submission programmatically.

7.B. Answer: FDA plans to replace the digital certificate with the FDA ICAM services, electronic signature, and Client ID/Secret key for API authentication and other credential needs.

Question: FDA mentioned at the February Quarterly meeting that the ESG NextGen will be agnostic to data types and will be able to ingest different file types. Is the planned scope of the ESG NextGen broader than the current ESG? Will the ESG NextGen be used for eCTD submissions only or will non-eCTD submissions be sent through the ESG NextGen as well?

8.A. Answer: FDA plans to offer broader ESG NextGen capabilities to enhance experience in user onboarding and management, submission preparation, large file upload, status tracking, two-way communication and user assistance. These capabilities will be rolled out in a phased approach. In the first phase, FDA plans to replace WebTrader with the new Unified Submission Portal that will work with major Browsers such as Google Chrome, Microsoft Edge, Apple Safari, etc.

8.B. Answer: ESG NextGen is designed to be agnostic to file types and will work with all file types currently supported by ESG. FDA currently does not have plan to support additional file types. New file types will be determined by the Centers and will be announced prior to FDA adopting the use. As before, ESG NextGen will accept both eCTD and non-eCTD submissions.

Question: Has the Agency performed any submission testing in the new environment? Can the Agency share information regarding the capabilities of the ESG NextGen (e.g., submission size and file size limitations)?

Answer: FDA is currently developing the Proof-of-Concept on some key functional areas. Performance testing is in the plan. FDA will share the new capacities such as file size limitation once they become available.

Question: The current ESG has provided some new administrative functions through the Account Portal for WebTrader users. Will the API have similar/same administrative functionality for all users (i.e., current WebTrader and AS2 users)?

Answer: Most likely, yes. ESG NextGen will provide and extend current ESG functionality as it pertains to account administration and file submissions in the Unified Submission Portal.