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
