Tag Archives: FDA

Current State of US FDA’s Electronic Common Technical Document (eCTD) Validation and Review Software Procurement and Implementation

We at LORENZ have been receiving an increasing number of emails and phone calls from our customers and partners concerning the current state of the project implementing LORENZ docuBridge, eValidator, and Automator at the U.S. Food and Drug Administration (FDA).

In order to clarify the chain of events and alleviate any concerns, we are outlining below a timeline of events we hope will be helpful.

Continue reading

USFDA eCTD Module 1 v2.3: Considerations for Transition

Introduction

One of the biggest changes to the electronic common technical document (eCTD) in the past few years was the introduction of the United States Food and Drug Administration’s (USFDA) newest module 1 specifications and corresponding technical files. The new specifications v2.3 and the XML Document Type Definition (DTD) v3.3 were developed to enhance USFDA’s ability to process eCTD submissions and enable additional submission types that were previously not accepted in eCTD format.

After a lengthy testing period, USFDA began accepting submissions using the new v2.3 specifications in June 2015 and has now received thousands of submissions using the new module 1. While uptake has been good, most submissions were applications being submitted to USFDA for the first time, starting from a clean slate with the new specifications.

Transitioning existing applications to the new module 1 adds complexity to eCTD publishing but should not be treated as roadblock. Here we will discuss preparing existing applications for the transition and ways to smooth the process for a successful transition.

Continue reading

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

Continue reading

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.
Continue reading

The NDA Marriage – Complementing Regulatory Strategies with Technical Solutions

Jillian Lee

The presentation “The NDA Marriage” was given by Jillian Lee, Senior Global Submission Specialist at Bayer Health Care AG, at LORENZ userBridge.14 in Milan, Italy.

In her presentation, Jillian Lee outlined an approach for concurrent submission applications.

Background: sequential regulatory requirements
Bayer’s mission is “Science For A Better Life”. For the pharmaceuticals division, this means – making available safe, effective, and potential life-saving options to patients as quickly as possible. Currently however, technical barriers prevent the submission of a NEW indication for a drug while the first indication is still in the initial approval process with health agencies.

So a solution is needed to reduce the overall review timelines and potentially help in “fast-tracking” approvals. The answer is simple, although technically complex: enable concurrent applications. Continue reading