arivis Regulatory Operations Tips & Tricks

Changes in the CTD M4

Posted by Yasmin Cherie on Aug 29, 2016 4:58:27 PM


Changes in the ICH CTD M4 (R4) Organization Document


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2016 DIA Annual Review – FDA Electronic Submissions Gateway (ESG) Update

Posted by Adair Turner on Jul 22, 2016 1:58:26 PM

The ESG and process for setting up new clients has always seemed outdated and overly complicated to me.  The updates La Misha Fields provided at DIA answered many of my questions and concerns.  I’m happy to say that I’ve seen some of the updates such as the automated messaging from the ESG helpdesk are already in place and helping.  Of course it is a work in progress and there have recently been many production outages, but progress is being made and the additional enhancements look promising. 

In her presentation, La Misha Fields provided an update on additional enhancements on the horizon, 2nd generation update, and the new Webtrader UI.  Please note that I have added my own personal comments to this post.  Click here to see La Misha’s presentation.

I’ll start with the best part!

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2016 DIA Annual Review – FDA Electronic Submissions Update

Posted by Adair Turner on Jul 15, 2016 2:55:50 PM

My favorite parts of DIA events are the Health Authority presentations so I thought I would share with you what I learned.  Ginny Hussong provided updates on:

  • Deadlines for requirement of eCTD and Standardized Study Data.
  • Current FDA submission statistics.
  • ESG Acknowledgements.
  • Notable upcoming FDA e-submission activities.
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Major Submission Planning – What is a Submission Manager and why do I need one?

Posted by Gerard Bradley on Jun 17, 2016 3:34:59 PM

There’s a lot at stake.  You’ve probably already spent a decade of time and millions of dollars to get to this critical point.  The entire fate of your company may by contingent on the approval of a single drug candidate.  Is this really the point that you want to take risks?  Probably not.  This is when you really want to make sure that you have an experienced team ready to take you across the finish line. 

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Promotional Materials Management

Posted by Gerard Bradley on Jun 9, 2016 2:42:39 PM

ll branded communications (aka promotion) disseminated by or on behalf of a pharmaceutical company are regulated by the FDA. 

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Topics: Promotional Material Management

How to capitalize on the 2017 eCTD Mandate

Posted by Gerard Bradley on Apr 14, 2016 2:28:33 PM

Under FDASIA and the reauthorization of PDUFA V, it will be mandatory to submit NDA, BLA, ANDA, and Master File submissions in eCTD format starting May 5, 2017. Commercial IND submissions will be mandatory in eCTD format starting May 5, 2018. The FDA receives an increasing number of eCTD submissions each year. CDER received 14,700 submissions in December 2015, however many companies are still submitting in paper format.

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