FDA CDER Integrated Work Management

Integrated Work Management (IWM) is bringing an array of favorable business benefits to CDER including improved control of information as a result of having a central repository, improved performance as a result of tracking information in one central location versus tracking in multiple systems or spreadsheets, and increased data minimization, which is one of the goals of the Federal Chief Information Officer (CIO) to better utilize government data. The primary advantage is that IWM may be deployed Center-wide as the system of record for work planning that relates to regulatory deliverables, as well as supplements and complements the official systems of records. This management solution will help manage a portfolio of work assignments for the Center. The IWM Business Case predicted an Organizational Cost Savings of $78 million over five years, and an additional Stakeholder Benefit of $24 million over that time. The organization cost benefits come from a consolidation of project, workflow and resource management relating to regulatory and other activities in the center, while the stakeholder cost benefits include accommodating the expected increases in drug approval volume, and reducing the approval backlog.

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