Category: XML

ARIM, ARIM Publisher, eCTD, eCTD 4, XML

eCTD 4: Unlocking Keywords, Part 2 (wonkish)

In the most recent post on eCTD 4 I explained the basics of how metadata that classifies documents in the electronic Common Technical Document (eCTD) is organized, and how ACUTA’s ARIM Publishing Module will need to evolve to support it. This post is going to get into the specifics of what must go on behind …

CMC, FDA, IDMP, XML

FDA’s Draft CMC Data Elements – IDMP’s New Buddy?

On July 5, 2017, FDA (United States Food and Drug Administration) published a new document to the Federal Register titled “Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Technologies.” This is a draft document describing data structures that could take the place of much of the eCTD (Electronic Common Technical Document). Public comment is …