Category: FDA

ACUTA, ARIM, ARIM Publisher, eCTD, FDA, Uncategorized, Validator

FDA Validation Criteria to change July 27

On June 21, FDA announced changes to their eCTD validation criteria, to be implemented on July 27. The first is to remove a low-severity item, #5025, which would highlight the lack of PDF-fillable forms. The rest are a set of new validation rules, numbered 1-7, that were previously part of their Submission Acceptance criteria — …

ACUTA, ARID, EMA, FDA, Health Canada, Software Release

ACUTA Regulatory Intelligent Documents (ARID) v1.1 Released

I’m pleased to announce that ACUTA has released version 1.1 of the ACUTA Regulatory Intelligent Documents, or ARID for short. ARID is a set of over 325 shell documents (up nearly 50 from the previous version) and a carefully curated set of Word tools combined with the most-used features from the ribbon, on a single …

ACUTA, ARCS, ARIM, eCTD, EMA, FDA

eCTD – What are you waiting for?

I’ve now been with ACUTA for a full year – this blog started about two weeks after I joined the company. From that first post, we’ve been reminding you that the electronic Common Technical Document (eCTD) – the way of packaging up everything from the thousands of documents to get a drug approved, or just …

ACUTA, ARCS, ARIM, ARIM Publisher, FDA, Software Release, Validator

Getting your STF in order

In 2003, ICH introduced the Study Tagging File (STF) in the electronic Common Technical Document (eCTD) format for electronic submissions to facilitate a way to associate all the documents and data files for a study. Initially the specification included two possible approaches for versioning the study’s items: Cumulative: A complete cumulative STF would be provided …

Canada, eCTD, eCTD 4, EMA, FDA, Health Canada

eCTD 4: Everybody in the pool! But no running!

This year’s Regulatory Information, Submissions, and Document Management forum presented by the DIA took place February 4-7 in Bethesda Maryland. I saw a lot of old colleagues from my employers over the decades, now dispersed throughout the industry, and heard a lot about where Regulatory Information Management is heading. For me, the most fascinating part …

ARCS, ARID, ARIM, FDA, Uncategorized

Last Minute Help on FDA Marketing Status Report

The US Food and Drug Administration (FDA) wants your valentines, or at least a letter saying that you love them so much, because they accurately listed your products in the “Approved Drug Products with therapeutic Equivalence Evaluations,” better known as the Orange Book. As part of the FDA Reauthorization Act of 2017 (FDARA), there is …

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 …