USFDA ESG NextGen Update: FAERS Submission Type Removal
USFDA ESG NextGen Update: The U.S. Food and Drug Administration (FDA) is developing its regulatory submission systems under the Electronic Submission Gateway NextGen (ESG NextGen) system. There was a significant change that has been made regarding the FDA Adverse Event Reporting System (FAERS) recently. Some forms of submissions to FAERS have been eliminated and cease to be effective without delay.
This is a major revolution in the life sciences organizations, pharmaceutical firms and regulatory teams that have relied on such types of submissions to report adverse events. It is essential to make sure that these updates are adhered to, which will guarantee that the regulations are aligned and that there can be no mistakes in submissions.
Removed FAERS Submission Types
The following table highlights the submission types that have been removed from ESG NextGen:| Center | Submission Type |
| CBER | AERS_ATTACHMENTS_PREMKT_CBER |
| CDER | AERS IND |
| CDER | AERS Attachments IND |
| CDER | AERS_Attachments_PREMKT |
| CDER | AERS_ATTACHMENTS_PREMKT_CDER |
| CDER | AERS_PREMKT |
Organizations currently using any of these submission types should immediately review their submission workflows. Using deprecated submission types may result in processing errors or delays in FDA review.
Next Steps for Organizations
In case any of the removed types of submissions is needed by your organization it is highly essential to shift to the relevant alternative as soon as possible. The FDA advises to address FAERSESUB@fda.hhs.gov concerning the appropriate type of submission to be used in the future.
This revision is in line with the continued action by the FDA to simplify the submission procedures and make the reporting of adverse events more efficient and compliant. With submission methods that are actively updated, your organization is able to keep operating as required without any interference.
How Masuu Global Can Help
Masuu Global assists life sciences organizations in overcoming regulatory change such as the ESG NextGen updates. Our team will assist in making sure that there is a seamless transition, assist you in adjusting your processes, and reduce the risks of non-compliance.
The necessity to keep up and remain responsive to FDA changes in order to remain efficient in operations and regulatory compliance. Contact our team to make sure that your FAERS filings are all updated with the current ESG NextGen provisions.