How to successfully implement the transition from Paper to eCTD
Make the Change!
In June 2021, 2253 Promotional Material and Accelerated Approval Product submissions are mandated to be submitted through eCTD. While there are other types of promotional materials, only two are subject to the electronic mandate according to the electronic requirement in section 745A(a) of the FD&C Act. Will you be prepared to make the change?
A lot goes into planning an eCTD submission, especially if it is your first sequence being electronically submitted. Promotional materials have new and specific metadata criteria, so having an action plan in place before June 2021 is crucial. Ideally, you would have your action plan in place 6-12 months in advance of the deadline, and even begin to submit your promotional material in eCTD before the deadline.
Are you prepared?
To ensure a successful transition from paper to eCTD, you will need to plan in advance of the deadline and submit your promotional material in eCTD format on time. Download our Whitepaper to see what you need to consider and how to be best prepared for June 2021!
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Di, 2020-02-11 09:53