Category: Uncategorized

ARIM, Software Release, Uncategorized

ARIM 3.3 Hotfix 1 Released

ACUTA (an IQVIA company) is pleased to announce the release of ARIM version 3.3 Hot Fix 1. This release includes a number of customer-requested updates and fixes. The key improvements are to our support for Veeva Vault repositories The use of Okta authentication has been made a System Setting, permitting it to be set up …

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 — …

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 …

Conferences, Uncategorized

DIA Canada October 16-18

Sorry for the short notice, but please come hear me present IDMP: International Data, Multiple Processes at the DIA Canada annual meeting in Ottowa October 16-18. I will be speaking in session 4C at 3:30PM on October 17, in the session Identification of Medicinal Products (IDMP)- Updates and Implementation Approaches, chaired by Maggie Graham of Health …