Monthly Archives: February 2016

Want to learn about new US Module 1 specifications? – Visit LORENZlink 2016 in April!

With the release of version 3.3 of its eCTD Module 1 specifications, the US FDA has enabled industry to streamline eSubmission processes. With these new features come added complexity that must be mastered to take full advantage of upgraded functionality. Join us at the inaugural LORENZlink RIM conference on April 4 – 5, 2016 in Scottsdale, AZ, for a detailed discussion of changes and lessons learned to ensure a successful transition to the new Module 1. You will learn about:

  • FDA experience with the new Module 1 including common validation errors
  • Considerations and best practices for transition
  • When and why grouped submissions make sense
  • Tips for preparing and submitting Promotional Labeling and Advertising in eCTD format
  • Updates on US FDA’s upcoming eCTD mandate

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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.
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