eSubmitter Application History
The FDA has updated the application history for its eSubmitter software, providing a reverse chronological record of all updates by version number.
Manufacturers of biological products, vaccines, and blood products who use the eSubmitter tool for electronic regulatory filings.
Access to version history is essential for ensuring that electronic submissions are prepared using supported software versions. Failure to maintain the appropriate version may result in technical rejection or processing errors during the submission of biologics license applications or other regulatory filings. This update indicates a commitment to transparency regarding the technical evolution of the agency's data intake portals.
Regulatory teams should verify that their current internal installation of eSubmitter matches the latest version in the FDA history log. IT and QA departments should document software version updates in their change control logs to ensure submissions are compatible with the agency's current processing specifications.
History of all updates to the application software in reverse chronological order by version number
Open in openFDA / FDA.gov