Those of us who were around in the Regulatory Affairs field during the late 90s probably remember the glory days of ESD, EVA, and CDOC, following the years of page-stamping in hallways that resembled assembly lines. Then came EVA, which was part of a system called the Electronic Submission Program, which was in turn, part of a larger strategy for electronic regulatory submission and review at the FDA.
The University of Maryland had developed the program for the FDA. The system (here) consisted of three components: the data standards, software, and data flows. The data file standard was the first of three data document standards. FDA developed this simple, text-based standard on the model of typical data files used for statistical analysis of data. The central text document of the submission was the Electronic Submission Document (ESD). This was a structured plain-text document that was designed to support automated data entry into a database. The Entry and Validation Application (EVA) was one of the first of three software programs to support the system. Since structured documents are not easy for direct data entry, the program offered a typical window, forms-based environment for data entry and provided a graphic view of the ESD hierarchy that was presented to the user.
Fast forward to 2018, and we are promised a brand-new platform. Scott Gottlieb, the Commissioner of the FDA, just announced an initiative (here) that will create a new review platform. The Knowledge-aided Assessment & Structured Application (KASA) platform will modernize generic drug review from a text-based to a data-based assessment. This will allow the FDA a structured and efficient review to provide earlier feedback to generic drug makers. According to the Commissioner, this is one of the key aims, and a primary focus of the overall efforts to reduce multiple cycles of application review, and speed market- access to new generic medicines.
It is not clear how far FDA is on rolling this out, but this system will also enable more efficient and robust knowledge management across the FDA’s review process. At present, FDA review is based on manual reading of the narratives in the application. This will enable automated and consistent analysis of some portions of the application. Upon implementation, KASA will benefit the agency and possibly the generic drug sponsors.
We have discussed in publications (here) about authoring language such as XML, and related editors that are readily available as open-source tools, in relation to adapting submission platforms that supports multiple media formats. The industry has already achieved some proficiency in using XML as part of the eCTD backbone. So, we will be looking forward to knowing more of the technical details and timelines of this exciting new platform and what would it take for the industry to implement it. As the Commissioner is moving fast to increasing the overall speed of the regulatory processes, is the industry ready for the upgrade along the journey?