5 steps to prepare for the FDA’s guidance on electronic submissions for promotional materials

On June 21, 2019 the FDA released final guidance related to the electronic submission of promotional materials. This guidance requires that by June 2021 promotional materials subject to the post-marketing submission requirements using Form 2253, and pre-submission process for accelerated approval products be processed through the gateway, and will no longer be accepted via paper or CD.

To help organizations establish the operational foundation for a seamless transition to eCTD, we recommend the evaluation and execution on five focus areas.


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