Scanning, a Thing of the Past
Apr18

Scanning, a Thing of the Past

Nowadays the word “scan” is a bad word. Scanned documents are more difficult to read and often the quality is lower. Further, scanned documents do not allow search or copy and paste text. During an electronic review, the ability to search and cut and paste text are very useful. Sponsors are reporting more and more rejections if scanned documents are submitted.

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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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Regulatory Publishing Considerations for Literature References

eCTD submissions frequently include literature references that are submitted to support aspects or statements made within the application. The articles that are provided in the submission are typically from scientific or medical journals that have been downloaded by the sponsor from sources such as the publisher or a service provider like Thomson Reuters. Downloaded articles are commonly formatted following a set of standards that do...

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PDF Document FAQs

Last month, I attended a conference focused on pharmaceutical regulatory writing and submissions in Baltimore, MD. During the two-day conference, a number of discussions and questions pertained to PDF files. As many of you may have similar questions or experiences, I wanted to share the questions and answers to provide some greater insight into PDFs in relation to electronic submissions. Q: What versions of PDFs are acceptable? A: The...

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