Move Production of eCTD Submission-Ready Documents Upstream
May18

Move Production of eCTD Submission-Ready Documents Upstream

The role of eCTD-ready source documents and their impact on submission timelines and publishing efficiency is a topic that has been debated for many years. There a lot of naysayers claiming that it’s not possible to compel scientists to produce submission-ready documents, CROs cannot be made to comply with requirements, etc.

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Free Educational Webinar: FDA Review Process

Update: the webinar slides are now available for download here. Navigating eCTD regulations and guidelines is easier said than done. Same goes for assembling and reviewing applications. That’s why GlobalSubmit and Cato Research are offering a free educational webinar on the FDA Review Process on Tuesday, March 1st at 3pm EST. The purpose of this webinar is to provide you with the complete FDA review process to make sure that you...

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Risks Associated with eCTD Refusal to File (RTF)

Recently, eCTD has been in the news in a big way. Acorda Therapeutics announced that it received a refuse to file (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Fampridine-SR, a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS). The FDA has raised what it termed “format issues” regarding Acorda’s eCTD (electronic)...

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FDA Talks Automated Technical Rejection

At the DIA Doc Management conference, the FDA presenters spoke with one voice on their intention to start rejection sequences that have what they consider significant technical flaws. Gary Gensinger reviewed the guidance that has been issued by FDA on this topic (see my previous post) and the three types of eCTD Validation: Automated Submission Receipt (ASR) Validation – automated step performed as your submission is accepted and...

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