Controlled Terminology Best Practices
Simplify Controlled Terminology with expert insights from Sarah Angelo. Overcome challenges, ensure compliance, and improve…
CertaraMarch 3, 2021
FDA’s New ANDA Submissions Guidance: Key Points
The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance…
CertaraSeptember 27, 2018
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
