DIA Update: News from the FDA

This year’s DIA annual meeting was more of a checkpoint rather than revealing startling new information – at least in the eSubmissions area.  However, a lot of interesting information was exchanged.  Today, I’ll focus on the FDA’s presentations.  I’ll follow up later with information from other authorities and industry.

Gary Gensinger provided his usual update on eSubmissions at the FDA:

·         In the CDER town hall meeting, Gary noted that FDA is looking at drafting legislation to require eCTD – however, this is a lengthy process and no target date is being released at this point.

·         As of shortly before the meeting, FDA had received a total of 6015 applications consisting of 72154 sequences.  FDA expects to receive in excess of 4500 eCTD sequences in July of 2009.

·         There are some interesting trends by application type:

o    52% of NDAs received are now fully electronic.

o    ANDAs have grown by 70% since November 2008 – a huge uptick.  If you’re in the generics industry and still submitting on paper, you are behind the curve.

o    While only 12% of INDs are submitted electronically (up by 1% since last year), 28% of IND Amendments are submitted electronically – a result of maintaining an ever larger number of INDs submitted electronically to date.  (By the way, I had an FDA reviewer who stopped by my booth mention that he cringes when presented with a paper IND these days…)

o    An impressive 83% of Efficacy supplements  are electronic, up by 12%

o    CMC  supplements are holding flat at 47% electronic

·         FDA is working on an agency level receipt date guidance (the current document applies only to currently only CBER/CDER)

·         Gary reminded sponsors that briefing packages must still be submitted in paper even if they are also submitted as an eCTD sequence.

Mark Gray gave an overview of RPS, and stated that RPS will be in production use at FDA by September 2011.  Mark and Gary mentioned that ICH will not be making any significant updates to the eCTD spec – there will be no DTD changes as ICH and the regulators look towards moving to RPS as “eCTD Next Major Version”.

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.

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