Category: FDA

ACUTA, ARCS, ARIM, eCTD, EMA, FDA

Your Holiday Gift: eCTD for Everything

A month ago, we reminded you that electronic Common Technical Document (eCTD) will be the rule for all US drug submissions on May 5, 2018, adding Master File and Investigational New Drug applications to the already-required New Drug Applications. What I’d neglected to mention is that eCTD is also expanding in 2018 for European submissions. …

ACUTA, ARCS, ARIM, eCTD, FDA

Six Months until Mandatory eCTD for INDs, DMFs at FDA

Almost seven months ago, I posted my first ACUTA blog entry on the FDA requirement for eCTD for all marketing applications, a little under a month before the May 5, 2017 deadline. The sky didn’t fall, companies didn’t fold for being unable to comply… and ARCS (ACUTA Clinical & Regulatory Services) helped numerous companies achieve …

ACUTA, ARIM, ARIM Publisher, eCTD, EMA, FDA

Lots of Regulatory Activity Going On

Welcome to another episode of Fun With RIM (kidding, this is the first one). Today’s topic: Just what is a Regulatory Activity? You’ll say to yourself, “I’m in Regulatory, and I do things, so those must be Regulatory Activities.” Not counting that 15 minutes to two hours that half the workforce spends every day on …

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 …

eCTD, eCTD 4, FDA

eCTD 4 — A Love/Hate Relationship

Joel Finkle, Director Regulatory Innovation & IDMP Strategy, ACUTA Don’t get me wrong: I definitely love eCTD 4 for all the things it’s been designed for. However, we’ve been working on it since 2005, and we’re still years away from its full implementation.  So, I thought I’d make a love and hate list to show …

ARCS, ARIM Publisher, eCTD, eCTD 4, FDA

eCTD – It’s not just a good idea, it’s the law

Joel Finkle, Director Regulatory Innovation & IDMP Strategy Note: This post appeared previously on LinkedIn.com Some of you have been following my writing for a few years; I’ve got a new home at Acuta. For others, this may be the first you’ve seen of my posts. I’ve been involved with electronic regulatory submissions since 1991 …