FDA eCTD Compliance For Drug Master Files

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.