FDA eCTD Submission Metrics, Role of Study Tagging Files

Announcement: See GlobalSubmit’s website for a brand new presentations page linking to recent agency presentations! GlobalSubmit recently attended two informative DIA conferences: The 8th Annual Electronic Submissions Conference “eCTD: The Adventure Continues” in San Diego The 10th Conference on European Electronic Document Management in beautiful Vienna, Austria During these conferences, industry received updates from a number...

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ICH, HL7 to Jointly Develop Next Major Version of eCTD

The ICH M2 ESTRI Main Page has been updated with the following announcement: “ICH M2 has initiated the development of the Next Major Version of the eCTD (eCTD NMV) to improve robustness, flexibility and long term stability of the message. In accordance with the decision by the ICH Steering Committee that technical specifications should no longer be developed solely within ICH, but should be created in collaboration with Standards...

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RPS Working Group Reviews ICH Requirements

The RPS (Regulated Product Submissions) Working Group met last week in Atlanta. The main discussion points were around ICH requirements, multi product submission, facility submissions, linking to other applications, multi regulator submission and how should the project be managed going forward. All current ICH requirements were reviewed. Most of the requirements are already met. Some more requirements need to be addressed. I expect...

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RPS Working Group to Discuss Next Major Version Requirements

The RPS (Regulated Product Submissions) Working Group is preparing for a September 23 working group meeting in Atlanta. Topics include: Discussion of analysis of ICH requirements list (by the way, were you aware that a list of ICH eCTD Next Major Version (NMV) requirements is available?) and multi-regulatory submissions Complexities around two-way communication for Master Files Labeling confidential information File and folder rules...

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FDA Statistics on NDAs, INDs and ANDAs

This year’s DIA annual meeting was more of a checkpoint rather than revealing startling new information – at least in the eSubmissions area. However, a lot of interesting information was exchanged. Today, I’ll focus on the FDA’s presentations. I’ll follow up later with information from other authorities and industry. Gary Gensinger provided his usual update on eSubmissions at the FDA: In the CDER town hall meeting, Gary noted that FDA...

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