FDA initiates performance monitoring program

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The FDA has launched a new organizational performance management system that will monitor more than 100 FDA program offices through data from key performance measures established each year, in order to promote transparency, public participation and collaboration in government work, stated the agency.

The initiative—FDA-TRACK (transparency, results, accountability, credibility and knowledge sharing)—will follow data gathered on a monthly basis, which will be analyzed and presented each quarter to FDA senior leadership. Additionally, via the FDA-TRACK website, the public will have access to track the agency’s progress.

According to the FDA, the system will monitor performance indicators in the following categories:

  • Common Measures: Agency-wide measures applicable to each of more than 100 program offices that may focus on the agency’s most recent priorities, including increasing the total number of employees who are trained in the Incident Command System.
  • Key Center Director Measures: Center-specific measures that are applicable to each center and are vital to the center’s priorities and strategic goals, including the increase of the agency’s number of technical publications drafted.
  • Program Measures: Program office-specific measures that are applicable to the office and reflect work important to the public and to the FDA’s mission, including the monitoring of the percentage of 510(k) decisions meeting the 90-day Medical Device User Fee Act goal during a specific time period.
  • Key Projects: Program office-specific projects that are applicable to the office and important to the mission and objectives of the office, including the development of a new risk-based approach for evaluating safety, effectiveness and quality of new animal drugs.

“FDA-TRACK will bring the operations of this historically opaque agency into the daylight and help us be even more responsive as we work to protect the public health,” offered FDA Commissioner Margaret Hamburg, MD.

Information regarding the latest performance data updates can be found on the FDA’s website.