FDA AERS Electronic Submissions Status Page

Updated Monday, May 05, 2007 08:30:00 AM

PLEASE NOTE:  The AERS system will be operational during Federal holidays, however no one will be available to monitor or research submissions on those days.

Adverse Event Reporting System (AERS) :

Current Status:  AERS is operating on the normal schedule.

Note:  Whenever the ESG Gateway is down, AERS electronic submissions system is also down.

AERS Normal Operating Schedule:

The FDA AERS system is available to FDA safety evaluators and reviewers 24 hours per day, Monday through Saturday.  The database is scheduled to be off line every Sunday from 10 p.m. until 7 a.m. Monday for backup.  The database is also scheduled to be off line the second Saturday of each month for testing and maintenance.  Individual case safety reports that are received electronically are loaded into the AERS database within 24 hours of receipt.  The FDA receipt date is always recorded as the date the report was received by the ESG Gateway. Questions about the AERS operating schedule can be sent to aersesub@cder.fda.gov.

For more information about electronic submissions to the FDA AERS system, go to the AERS Electronic Submission Page.

*All times on this page are U.S. Eastern Time Zone