US FDA Previews Future Direction of Electronic Submissions Programs

Jared Lantzy, Manager Global Regulatory Agencies and Processes at LORENZ Life Sciences Group, compiled a short summary of current and future technology initiatives at FDA presented at the 2016 DIA RSIDM.

Brad Wintermute, the Deputy CIO and Director of the Office of Technology and Delivery at FDA, opened the 2016 DIA Regulatory Submissions, Information, and Document Management Forum (DIA RSIDM) on Monday, February 8, 2016 by outlining current and future technology initiatives at the agency. It is very refreshing to see agency leadership not only paying attention to electronic submissions programs but identifying these programs as priorities essential to FDA’s mission.
Highlights of Mr. Wintermute’s keynote included:

  • The next generation of the Electronic Submissions Gateway (ESG) should be implemented in 2016. FDA’s ESG is estimated to receive 6.5 MILLION submissions this year and submissions are likely to grow to 18 – 20 million by 2020! The next generation promises improvements in speed, performance, and new features to assist regulatory operations in submission tracking.
  • FDA is investigating creative solutions to submission storage and transmission including a mention of cloud-based or cloud-shared review. As submission sizes continue to climb, FDA must manage its own growing submission archives. Moving some of the burden to industry or to a shared private cloud is an interesting idea that could also enable simultaneous review by multiple regulatory authorities and lead to faster approvals in multiple markets.
  • An affirmation that FDA is committed to implementing the same IDMP standards as their European counterparts. However, FDA has still not identified a timeline for mandating IDMP. The European mandate will continue to drive IDMP adoption by industry.

Hopefully FDA will follow this update by senior leadership by pushing for an alignment in electronic submission programs across all centers. There are advancements in regulatory publishing coming soon (RPS) that can help industry reduce costs if FDA centers can agree to accept the same standards for regulatory review.

Jared Lantzy
Written by Jared Lantzy, Manager Global Regulatory Agencies and Processes at LORENZ Life Sciences Group.

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