Should all Documents in an eCTD have a Table of Contents and Bookmarks?

Most documents in an eCTD submission that have more than four pages of content include a Table of Contents (TOC). When TOCs are present, files are bookmarked to match the TOC. Furthermore, when documents have Lists of Tables and/or Lists of Figures, the documents are bookmarked to match those entries as well. What if documents don’t contain a TOC?  Is it necessary to add one? Not necessarily. Bookmarks can be used to aid reviewers in...

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Specifications for eCTD Validation Criteria 2.2: PDF Checks

FDA implemented eCTD validation criteria 2.2 on April 30, 2013. This version of the validation criteria includes PDF checks to ensure compliance with FDA PDF Specifications V2.0, Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications, ICH eCTD Specification V3.2.2, ICH Q&A, as well as promote general good practice to ensure reviewability.

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Does the FDA Accept PDF/A?

Recently a client asked me if the FDA would accept a PDF/A document. The short answer is yes, but I would not build your system based on the PDF/A standard. I will explain why below. PDF/A is an ISO-standardized version of the Portable Document Format (PDF) specialized for the digital preservation of electronic documents. PDF/A differs from PDF by omitting features ill-suited to long-term archiving, such as font linking (as opposed to...

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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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eCTD Publishing Best Practices
Mar09

eCTD Publishing Best Practices

People seeking advice on eCTD publishing best practices usually fall into one of two groups: (1) Sponsors who are new to eCTD, for example, medical writers or project managers (2) eCTD publishers. The first group is usually interested in specific actions they can take to make their specific submission a success, while the latter group is more interested in strategic ideas on how to make their processes work better for all submissions.

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