Category: ARCS

APT, ARCS, ARID, ARIM, Conferences

Speaker’s Corner, 4Q 2018

Joel Finkle will be speaking at the Drug Information Association (DIA) eDM 2018 – Clinical and Regulatory Operational Excellence Forum in Barcelona Spain, November 29-30, 2018. He will be speaking on the intersection of Component-Based Authoring (CBA) and Regulatory Information Management (RIM), in a presentation titled, “All the Way Around the RIM: From Registration Data …

ARCS, ARIM, Canada, Health Canada, Medical Devices

Health Canada Updates Medical Device Submission Format

Canada XML

On August 21, Health Canada announced that they would be adopting the IMDRF “ToC” format for medical device market authorisation requests. As of April 1, 2019, Premarket Applications for Class III and IV devices (which aren’t the same classification as FDA’s Center for Devices and Radiological Health) will need to be in this format, and …

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 …

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, APT, ARCS, ARID, Conferences

Forum Exchange: Come visit ACUTA at Booth 310 at the DIA RSIDM Conference, February 5-7

The annual Drug Information Association Regulatory Submissions, Information, and Document Management Forum (DIA RSIDM, for short) is February 5-7 in Bethesda Maryland. Come meet members of ACUTA’s product and business development groups, including Don Palmer, Director of Product Strategy Scott Higgins, Business Development Manager Joel Finkle, Director Regulatory Innovation Shylendra Kumar, President and CEO We …

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. …

APT, ARCS, Software Release

I’m APT to be a little excited over version 4.0

The holidays came almost two months early for users of ACUTA PDF Tools (APT) as version 4 was released on October 31, 2017. With the new release, APT continues to evolve to work with new guidance, as well as features that improve publishing processes for Bio/Pharma companies using it to assemble their submission-ready documents. A key …

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, ARCS, ARIM, Australia, eCTD, NeES

E-Submissions Looking Up Down Under

Australia’s Therapeutic Goods Administration (TGA) released updated guidance for both eCTD (electronic Common Technical Document) and NeES (Non-eCTD Electronic Submissions). Version 3.1 of the Australian regional eCTD specifications, and version 2.0 of the NeES specifications will be accepted starting January 1, 2018, and will be mandatory July 1, 2018. Because the eCTD and NeES are …