How We Moved to Agile for Regulatory Submissions and Why It Works
Sep10

How We Moved to Agile for Regulatory Submissions and Why It Works

Agile is a process framework that has been used to manage complex product development since the early 1990s. Working within the Agile framework, you can employ various processes and techniques. For the purposes of this article and our entire series of articles, the relative efficacy of regulatory publishing practices guided by the Agile methodology are made clear so that you can understand the process and its advantages.

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The Undocumented STF Lifecycle Management
Nov12

The Undocumented STF Lifecycle Management

A number of sponsors have recently inquired as to the proper use of the modified-file attributes (operators) when using Study Tagging Files (STFs). Our research has yielded a number of helpful findings on the subject.

The Lifecycle Management section (page 10) of the latest ICH guidance on eCTD Backbone Files Specification for Study Tagging Files incorrectly states that the modified-file attribute of “append” is used to control lifecycle operations of that STF. While the documentation is wrong we don’t expect a timely update.

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Compound Documents Left Out of RPS Standard
Jun06

Compound Documents Left Out of RPS Standard

Compound documents will not be part of the Regulated Product Submissions (RPS) standard. The decision was recently announced by the International Conference on Harmonisation’s (ICH) M8 working group which had been deliberating on a number of negative ballot comments registered in September 2013.

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The Latest on FDA Tobacco Submissions
Aug08

The Latest on FDA Tobacco Submissions

The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) and the tobacco industry are in the exploratory stages of developing a standard for electronic submissions. Statistics on tobacco product applications evaluated to date combined with the scant regulatory experience of the industry indicate that progress toward a standardized submission and review process will be deliberate.

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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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