PDUFA V Includes eCTD Mandate for Marketing Applications, Commercial INDs

In September, the FDA issued its Proposed PDUFA V Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017. There are many proposed improvements related to the FDA review procedures, including a mandate of the eCTD. This mandate will start 24-months after publication of the corresponding final guidance for marketing applications and 36-months after publication of the final guidance for commercial INDs and...

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eCTD Submissions Q&A

Under the draft PDFUA V bill, electronic submissions will be mandated in Q2 2015. Given this recent news, GlobalSubmit offered this free webinar to provide a comprehensive overview of the eCTD, including everything from basics and terminology to rules and regional standards to submission output and solutions, and more. If you were able to join us, we hope that you now feel better prepared to make the switch from paper to eCTD. We...

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Free Webinar: Introduction to eCTD

As you may already know, under the draft PDFUA V bill, electronic submissions will be mandated in Q2 2015. Are you prepared? Navigating eCTD regulations and guidelines is easier said than done. Same goes for assembling and reviewing applications. Your application must be technically sound and structured correctly. Most importantly, it has to be ready for review by the agency upon submission. GlobalSubmit Inc., a leading developer of...

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eCTD Mandate to Follow 2-Year Implementation Timeline

The draft guidance will be open to comment for a period of 6 months followed by the release of the final version. It will then be implemented 2 years after the final version, bringing us to mandated electronic submissions in Q2 2015.

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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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