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What You Missed During FDA’s Presentations at DIA RSIDM

March 23, 2016 | BJ. Witkin, Senior Manager | Regulatory Operations

As I wrote recently, I attended DIA’s RSIDM conference this year. The highlight of the conference is always FDA’s presentations—they give the opening (“FDA Update”) and closing (“Ask the Regulators”) talks. This year wasn’t as exciting as last year, when FDA broke the news about the new Module 1 and the eCTD mandate, but there was still some news. Here are the big things I heard:

More submissions are going eCTD

The following data were presented by Ginny Hussong, Director, Division of Data Management Services and Solutions, CDER:



  • There were 14,700 ESG submissions to CDER in December 2015, its highest month ever.
  • There were also 1600 ‘new Module 1’ submissions (using 2.3 specifications) as of February 1, 2016.
  • 88% of study data submitted in support of new NDAs were submitted in CDISC format.
  • 75% of study data submitted to NDA submissions were in standardized SDTM format (FYQ1-Q2 partial).

Changes for FY2016-17


  • More information added to 2nd (Center) Gateway Acknowledgement

    I’m not sure what info will be added, but they also want to make it more “human readable” (YAY!).

  • Addition of a 3rd Gateway Acknowledgement

    This will be a confirmation of technical acceptance or rejection. Currently there is a system which tells the submitter if something has been rejected for technical reasons, but the rejections display in an area which isn’t obvious and sometimes the rejections show up days or even weeks later. This third acknowledgment would come within a defined amount of time and would display in the same place as the normal acknowledgments.

  • ESG 2nd generation

    FDA will also upgrade the ESG servers, software, and transmission capabilities over the next 8 months in anticipation of the increased traffic (they expect a 500% increase by 2019) from the eCTD mandate. They expect this will improve the overall performance (YAY!). This upgrade will take place in 2 phases, with Phase 1 (software updates to reduce submission time through the gateway) happening March 28th. Phase 2 (hardware upgrades) will occur in December. This will also allow submissions of up to 1 TB!

  • Planning for eCTD v4.0 implementation

    If you read my other blog post from DIA RSIDM you’ve heard about the changes eCTD v4 will bring. Those changes will also require FDA to update a lot of its systems. At the very least they’ll need a new viewer and new validation software.

Validation errors and tips to avoid them

Jonathan Resnick of FDA’s Electronic Submission Support Team gave a presentation providing metrics about the new Module 1 and the top 10 validation problems they’re seeing at FDA. Even better, he gave some helpful tips on how to avoid them and/or make reviewer’s lives easier. As you’d imagine this was a long presentation with lots of info—too much for me to go into in this post. Stay tuned for a separate post in the next few weeks!

ESG Help Desk metrics

La Misha Fields, IT Program Manager for the ESG Esubs group (the people we contact when we have questions about eCTD or the ESG), shared some metrics and news about improvements to the support model. One example: about 53% of their 5,000-7,000 help desk tickets monthly are requests to create new accounts (the number of new accounts request is artificially inflated; see my final bullet below in Ask the Regulators). She told us that they’ve greatly improved the account setup process. It used to take up to two months to get a new account; they now have it down to about a week.

Ask the Regulators

The final session of the conference is always “Ask the Regulators.” Over the course of the 3-day conference attendees submit their questions; the FDA attendees do their best to answer them all in this always-informative panel. As you’d expect, there were a lot of questions. Here are the ones I found most applicable to me and the applications IMPACT supports:

  • They recommended including the number of files and the application size (approximately) in the cover letter BUT it is not necessary to include the virus scan info.
  • eCTD OPDP (marketing material) submissions will be mandatory 2 years after OPDP publishes their final guidance, whenever that happens.
  • There is no requirement to resubmit paper DMFs in eCTD format in May of 2017 when the eCTD mandate kicks in. However, any updates must be submitted electronically after that date.
  • The Quality Overall Summary should be updated repeatedly throughout the NDA’s lifecycle (note this is a change from previous policy).
  • Send big submissions after hours when possible! If a submission is critical path, please contact La Misha Fields directly before sending it.
  • Even though the new module 1 has a metadata field for the Technical Point of Contact for each submission, FDA would like that info included in the cover letter as well. The Esubs staff in the receiving room may not have access to the cover letter, or the reviewer may not know how to look up the Point of Contact using the Viewer.
  • File size limit: until about 2 years ago the official limit for one file in a submission was 100 MB. The limit was upgraded to 400 MB, but FDA says they’ve successfully tested over 500 MB files.
  • Multiple ESG accounts (my personal pet peeve): FDA policy says that CROs must have a separate ESG account for each and every one of the sponsors for whom they submit. This is a ridiculous requirement—last year Ginny Hussong of FDA agreed when I said as much and told us she was looking to get the policy changed. Well, I asked again this year…and no luck. Ms. Fields of FDA said they’ve sent it to the Office of Chief Counsel for review of the policy. I’m not holding my breath waiting for a response, even though I know most CROs are already not complying (IMPACT complies, in case you’re wondering).

There’s lots of information here as usual. Personally, I’d love it if FDA would do something like the Ask the Regulators session once or twice a year and open it to all of pharma. Sure, we can ask these questions, but it seems to me that if I’m wondering about something, I’m probably not the only one who has that question!

Category: Regulatory Operations
Keywords: DIA RSIDM, eCTD v4, XML backbone

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