This short 25-minute webinar covers the new electronic Common Technical Document (eCTD) that is FDA mandated for all Drug Master File (DMF) submissions and Letters of Authorization (LOA) as of May 5, 2017. Selig’s Director of Regulatory Affairs, Owen Smith, briefly covers the current system and its drawbacks, then explains the FDA’s new eCTD and the Electronic Submission Gateway (ESG) for DMF access.
Additionally, this webinar will help clarify the background for the change to eCTD, the benefits it will bring and Selig’s preparation for the FDA’s May 5th deadline and what you can expect.
Topics Covered:
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