FDA to Re-Organize eCTD Portions of Web Site, Clarify Content

Many of you are already familiar with the FDA’s Electronic Regulatory Submissions and Review pages.  Within the next few weeks, look for a significant update to these pages.

Some planned changes include:

  • Considerable re-organization, including creating new pages and deleting existing pages (so you may have to update your favorites and shortcuts)
  • Clarification concerning some recent changes.  For example, you may have noticed that the link entitled “eCTD Backbone File Specification for Modules 2 through 5 3.2.2” now points to the ICH eCTD 3.2.2 spec, instead of the FDA’s document, but to date they had not commented on this or formally withdrawn their own document.  They will clarify this when they update their pages.
  • At some point shortly after the re-organization, they will post updated validation criteria.   This development has been awaited for some time by sponsors, as the FDA moved to a new version of their validation software (GlobalSubmit VALIDATE 5) last November but had not yet posted the updated criteria associated with the new version.

Updates to electronic forms are not part of this effort.  There is a separate working group with a goal of standardizing all of the forms and making them fillable.

I will highlight the update and any significant changes when it takes place.  If you want to avoid having to check in, I suggest that you add this blog as an RSS feed (see the top left of this page or use your IE toolbar) and then you will receive a notification email.

Article written by

I am GlobalSubmit’s director of professional services. My area of expertise is electronic document management and regulatory submissions, specifically eCTD. I have 12 years of biopharmaceutical industry experience in the US, Europe, Israel and Japan, concentrating on content management for Regulatory Affairs & Submissions, Clinical Development, and Manufacturing, and in submission assembly and publishing. I have worked with over 50 pharmaceutical clients. Previously, I was the practice lead for the Subject Matter Experts/Business Analysts group at First Consulting Group (FCG), now part of CSC. I supervised a group of 12 SMEs/BAs. I was instrumental in the development of the FirstDoc® suite. I developed the project delivery methodology for FirstDoc® R&D, including training materials, project plans, workshop methodology and materials, and requirements and design specifications. I managed the design and development of FirstDoc® GMP and FirstDoc® Legal. Please feel free to contact me at kathleen.clark@globalsubmit.com if you are interested in talking about eCTD products or consulting services, or if you have ideas for the blog.

One Response

  1. Shakul Hameed
    Shakul Hameed April 29, 2009 at 8:52 AM | |

    Thank you for your kind information.

Please comment with your real name using good manners.

Leave a Reply

You must be logged in to post a comment.