FDA Implementation of eCTD Module 1 Update Scheduled for Q4 2014

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The biggest change in the history of eCTD is one step closer to implementation.

According to a notice posted this week on its website, the US FDA will be able to receive submissions using the new Module 1 specifications in the 4th Quarter of 2014. Industry will be given 30 days’ advance notice.

The long-awaited update to the eCTD’s administrative section is designed to:

  • Reflect regulatory changes
  • Provide clarification of business rules for submission processing and review
  • Refine the characterization of promotional marketing materials and advertising material
  • Facilitate automated processing of submissions

In conjunction with the announcement of a revised timeline for Module 1, the FDA published final versions of relevant support documents and specifications.

 

http://theectdsummit.com/2014/02/fda-implementation-of-ectd-module-1-update-scheduled-for-q4-2014/

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One thought on “FDA Implementation of eCTD Module 1 Update Scheduled for Q4 2014

    DR ANTHONY MELVIN CRASTO Ph.D responded:
    March 13, 2014 at 9:24 am

    Reblogged this on New Drug Approvals.

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