October 11, 2012 - 11 October 2012: On September 18, FDA held a meeting to present the final versions of the updated guidance for Version 2 of their eCTD Module 1. As I reported previously, FDA had several items that needed more than just a minor change to the regional backbone for eCTDs, and issued guidance almost a year ago describing what they wanted to do. The meeting in September clarified a lot of their intentions, and presented the revisions they’ve made in response to public comments.

October 10, 2012 - 10 October 2012: For many years, pharma companies have been investing heavily in enterprise content management (ECM) solutions, usually acquiring large, bespoke solutions that have enormous capacity but that have been expensive to purchase and maintain.

October 3, 2012 - 3 October 2012: Cost reduction and flexibility are seen as the top benefits for pharma companies transitioning to cloud or as a service, according to a CSC survey of senior industry executives from 11 leading pharma companies. In an era where cost cutting is top of mind, the need to find less expensive and more flexible solutions is clearly a priority and any opportunity to achieve those goals is highly sought after.

September 25, 2012 - 25 September 2012: The SAS XPORT format that has been in use since 1999 (before the eCTD era) is long in the tooth, doesn’t include metadata to show data relationships (which is why we have a complex define.xml file to describe it separately), and in fact the date stamp on the XPORT file isn’t even Y2K compliant! (the data within the file is, though)

September 20, 2012 - 20 September 2012: There’s been increased talk in life sciences circles about the way they manage their content, and all this is coming about because of a convergence of factors.

September 12, 2012 - 12 September 2012: Over the past several years, life sciences companies have confronted several safety and compliance manufacturing challenges and scares, which have led to heavy fines, billions in lost revenue and an industry that is increasingly focused on quality management and oversight.

September 5, 2012 - 5 September 2012: The first -- and probably biggest -- is the elimination of the “append” operation on leaf elements. This caused problems over the long life cycle of a document in a submission, especially when there were multiple rounds of appending and replacing, such as a protocol filed to an IND. The eCTD 3.2 specification doesn’t have any way of saying, “This is a replacement of an appended document” as opposed to “This is a replacement of the original document” because they would have the same ID.

August 27, 2012 - 27 August 2012: Pharma companies have a fairly significant challenge facing them, which is to integrate a heterogeneous set of solutions in order that these solutions can work together and enable good decision-making and regulatory compliance. One option they face is custom development involving many vendors and at significant cost. The other pathway is a scenario CSC is proposing, in which the pain of integration is removed before it gets to the company through an end-to-end solution that presents a more cohesive approach to industry challenges.

August 22, 2012 - 22 August 2012: Looking at pending regulatory changes, I have to wonder if a lot of regulatory affairs and operations are planning on retiring by 2014, because the following year there’s a lot of changes coming.

August 14, 2012 - 14 August 2012: eCTD 4.0 is the implementation of the Electronic Common Technical Document using the RPS (Regulated Product Submissions) standard developed at HL7. RPS came about originally as an FDA initiative to create a single submission standard that can be used for all its divisions: not just eCTDs for drugs and biologics, but veterinary, food additives, cosmetics, devices (and perhaps tobacco).