ESG NextGen Frequently Asked Questions
Will ESG NextGen allow the creation of one user account that all users for the company can use?
Will users be able to submit on behalf of another company (sponsor) and how will that work?
Will Non-Repudiation Letters and Authorization Letters need to be re-uploaded to ESG Next Gen?
Can an Agent/Consultant be able to utilize API submissions on behalf of their clients?
Where will Non-Repudiation Letters and Authorization Letters be uploaded?
Will Sponsors be able to delegate to CROs?
Does the FEIN replace the DUNS and is the EIN or FEIN field required during Company registration?
Will user account information and role assignment migrate over from ESG to ESG NextGen?
Will Non-Repudiation Letters be transferred over from ESG to ESG NextGen?
Will a Power User be able to update a Non-Repudiation Letter on behalf of a standard user?
What user roles will be available in ESG NextGen?
How many Power Users are allowed in ESG NextGen per company?
What happens when a Power User leaves the company?
Will a test submission be required prior to a production account being approved?
If a company utilizes an agency/consulting/CRO to upload on their behalf, do we still have to submit a Non-Repudiation Letter for ourselves/company?
How do you register as an Agency/Consultant/CRO?
Will AS2 users need to create an account in ESG NextGen?
How do Agency companies select the Sponsor Company in the dropdown?
As a Power User, can I assign the Power User role to a colleague?
How will Acknowledgements be delivered?
Where will Acknowledgements be available/accessible within the platform?
What Acknowledgements will be supported?
Will Acknowledgements be able to be received via API?
Will AS2 continue to support gateway-to-gateway communication for the Acknowledgements?
Can a shared email inbox be utilized to send Acknowledgement to?
What are the benefits of ESG NextGen over legacy ESG?
How will the industry be notified of ESG NextGen go live date and what materials will be available to prepare the industry?
Will all centers migrate to utilize ESG NextGen at the same time?
When will industry testing begin?
When will ESG NextGen be live (Release 1) for the industry and centers to use and what is included?
How do I sign up to participate in the industry testing phase?
Is ESG NextGen replacing ESG WebTrader?
What happens to submissions where the user is waiting on Acknowledgement feedback when ESG NextGen goes live?
Will there be a support desk available with ESG NextGen?
Is Multi-Factor Authentication mandatory? If so, what method will be available?
What is API, who can utilize submitting via API, and what is the format?
When will draft API specifications be available and will sample API code be provided?
Are there any limitations with API?
Size, number of calls, etc
When submitting an eCTD through the API, should the submission be compressed (tar.gz) prior to submitting or can the uncompressed folder structure be utilized?
Where are API credentials generated and when do they expire?
Will the API interface support both synchronous and asynchronous calls?
Will sequences be able to be submitted?
If ESG NextGen Unified Submission Portal (USP) is down, will API submissions still work?
With API submissions, what checks will be performed on the submission and what notifications will be received?
What is ESG NextGen replacing?
Will eSubmitter remain available to prepare submissions once ESG NextGen goes live?
Will historical submissions with acknowledgements be available in ESG NextGen and who will be able to access them?
Do users need to install anything on their PC to use the transfer agent for file/folder uploads?
Will your browser window need to remain open until the file upload is complete?
Are there any helpful tips to be aware of before uploading a new submission via the Unified Submission Portal?
Does the Unified Submission Portal replace eSTAR?
What are all the ways files may be submitted to ESG NextGen?
If a digital certificate is no longer required to transfer submissions, will the submission still be encrypted during transfer?
Will existing PFX submission key work for the ESG NextGen portal?
What can be submitted via ESG Next Gen?
Will ESG NextGen support Health Canada?
Will the upload of a digital signature be supported with ESG NextGen, or will the submitter have to sign each submission (when submitting via the Unified Submission Portal)?
Do e-signatures on submissions have to match the e-signature on the Non-Repudiation Letter?
Will ESG NextGen support test submissions?
Can a user submit via the Unified Submission Portal, API, and/or AS2?
What if the submission is over 1 Terabyte (TB)?
Since ESG NextGen will be preforming a virus scan on all submissions, is the virus scan letter requirement still in place?
What needs to be done to continue to submit via AS2?
Does the submitter have to be listed within the reports uploaded for ESG NextGen to accept the submission?
Can one person who is not an agent submit for multiple companies?
If a company has to submit reports which span multiple Centers, does selecting a single Center hinder this distribution?
Will the Unified Submission Portal be accessible from all countries?
Who will be able to see submission history/packages and what is available to view?
What web browsers will be supported by ESG NextGen?
Will Centers be able to communicate with submitters via the Unified Submission Portal (USP)?
Will submitters be able to view or download the files they have submitted within ESG NextGen Unified Submission Portal?
Will submissions uploaded via AS2 be available within the ESG NextGen Unified Submission Portal (USP)?
To provide feedback, please email ESGNGSupport@fda.hhs.gov