Panorama: FDA’s New IT Based Project Management System
​[Posted on: Thursday, December 17, 2015] 

FDA has had a serious issue at hand to manage the enormous work-load of its employees. Each Center at FDA receives a few thousand documents to review and has to follow strict time-lines for review and comment. Just the Center for Drug Evaluations and Research (CDER) receives about 150 new NDAs and BLAs applications, about 1600 ANDAs and about 400 new INDs. CDER is staffed by about 6000 employees about 80% of which are reviewers and the rest project management staff based on publicly available information. As would be obvious, the enormous number of documents to review along with the large number of employees creates a project management conundrum. To manage it workflow and streamline review outcomes, FDA launched several updates to its informatics systems. One of the most important of these is an IT system called Panorama. Panorama is used for management of core functions such as reviewer assignment, tracking of review status and outcome, and internal team communications. This week FDA announced that it has completed implementation of Panorama for the Office of Generic Drugs (OGD), and plans to implement it over other departments within CDER in the year 2016 and . Our sources tell us that Panorama is a unique tool custom built for FDA which involved mapping all the review and project management tasks and implementation of automated task assignment, tracking, status updates, and communications. This system allows tracking of a given document from the moment it arrives at CDER till it review is completed and outcome filed. It allows FDA’s staff to get automated updates on assigned tasks, keep track of team progress and prepare progress reports for management. It is also used for performance tracking and preparing reports. The details of the system are not publicly known but per the announcement, Panorama has already helped OGD meet its performance goals for this year and is being expanded to include additional elements per the reviewer requests. Our sources tell us that Panorama has had a huge impact on the efficiency of departments where it was implemented. FDA personnel worked closely with the developers to map internal processes, and tested the system to improve its accuracy. It is getting great reviews from its users. This integrated standardized work platform was highly praised by Janet Woodcock, the Director of CDER in a recent announcement with plans to implement across CDER over the next few years. It would be interesting to see the details of a smart workload management tool like Panorama, which could have applications for FDA-regulated industry.