FDA to Answer ESG Submission Surge with Usability Enhancements

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The Center for Drug Evaluation and Research (CDER) received a record-setting number of submissions via the Electronic Submissions Gateway (ESG) in December 2015 and if FDA projections are even remotely accurate, the overall count of submissions transmitted to the Agency in 2016 will dwarf previous totals.

More than 3 million submissions were received via the ESG in 2015, and FDA representatives are estimating 7 million submissions for the year 2016. The volume increase is quite substantial considering 11.3 million submissions passed through the ESG in the previous 10 years (January 2006 to January 2016).

A third ESG acknowledgement is among the FDA ESG system enhancements planned for 2016

Small user improvements planned by the FDA, and announced at DIA RSIDM 2016, will make life easier for sponsors who are growing more dependent on their Gateway accounts; the ESG user base is projected to grow to 23,000 in 2016.

A third ESG acknowledgement message confirming successful eCTD submission processing is in the works while the existing second ESG acknowledgement will be bolstered by more “human readable” information. Current acknowledgements contain elements like unique identifiers and time/date stamps.

Additionally, FDA representatives are hopeful that the 2-month process of setting up an ESG account will be significantly shortened to as little as a week.

Receiving a growing volume of submissions will also require technological improvements. The FDA expects to have 2nd generation ESG technology in place by as early as March 2016. System enhancements could allow the Agency to receive electronic submissions as large as 1TB.

The FDA does publish monthly statistics on ESG submissions received by all departments. Click here to access the submissions statistics archives.

Author: GS

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