BaseCase Interactive Brochure for Pharma
Jieun Choe2020年6月21日
FDA’s New ANDA Submissions Guidance: Key Points
The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance…
Rob Labriola2018年9月27日
Achieving Compliance with the FDA’s eCTD Mandate
The US Food and Drug Administration (FDA) has set 2018年5月5日 as the compliance…
Rob Labriola2018年5月4日
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…
Jason Rock2016年9月13日
Submitting eCTD in Advance of a Milestone Application
While advanced GPS systems and the advent of Big Data analytics are negating some of…
Rob Labriola2016年5月10日
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…
Evan Richardson2016年3月14日
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…
Emily Onkka2014年2月5日
