FDA Module 1 Update Set 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.

eCTD M1 Documents:

eCTD M1 Supportive Files:

Another item of note in the release of information on the implementation of the new Module 1 is the redesignation of ‘Prereview of television advertisements’ from 503B to 503C (21 USC 353c). The eCTD heading “ Promotional materials submitted pursuant to section 503B” is being changed to “ Pre-dissemination review of television ads.”


Author: GS

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