Achieving Compliance with the FDA’s eCTD Mandate
The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance…
CertaraMay 4, 2018
FDA’s New Module 1 is a Bridge to eCTD 4
Editor’s note: Jason Rock served as Project Lead for the HL7 RCRIM Expert Working Group…
CertaraSeptember 13, 2016
Submitting eCTD in Advance of a Milestone Application
While advanced GPS systems and the advent of Big Data analytics are negating some of…
CertaraMay 10, 2016
Best Practices for Placing Drug Master File Reference Letters in Regulatory Applications
Within drug applications (ANDA, BLA, IND, or NDA), eCTD (electronic common technical document) Module 3…
CertaraMarch 14, 2016
Hyperlinking: Making the Most of Navigation in eCTD Submissions
When authors generate documents intended for electronic submission they use blue-colored font to indicate where…
CertaraFebruary 5, 2014
