• Safety & Recalls
  • Regulatory Updates
  • Drug Coverage
  • COPD
  • Cardiovascular
  • Obstetrics-Gynecology & Women's Health
  • Ophthalmology
  • Clinical Pharmacology
  • Pediatrics
  • Urology
  • Pharmacy
  • Idiopathic Pulmonary Fibrosis
  • Diabetes and Endocrinology
  • Allergy, Immunology, and ENT
  • Musculoskeletal/Rheumatology
  • Respiratory
  • Psychiatry and Behavioral Health
  • Dermatology
  • Oncology

FDA launches new organizational performance management system to advance transparency

Article

FDA has launched a performance management system designed to advance transparency, public participation, and collaboration in the work of government.

FDA has launched a performance management system designed to advance transparency, public participation, and collaboration in the work of government.

The system, FDA-TRACK, will monitor more than 100 FDA program offices through data from key performance measures established each year. The data will be gathered monthly, analyzed, and presented each quarter to FDA senior leadership.

FDA-TRACK is designed to be informative, encourage accountability among FDA employees, and make their work more transparent. It gives managers and employees a new way to measure their effectiveness in meeting goals to protect public health, and it provides a way for the public to monitor agency activities. The public will be able to track this data and the agency’s progress through the FDA-TRACK website, www.fda.gov/AboutFDA/Transparency/track/default.htm.

Adapted from several successful state and local performance management models, FDA-TRACK hopes to set the standard for open government at the federal level. The system monitors performance indicators in 4 categories:

Common measures - Agency-wide measures applicable to each of more than 100 program offices and may focus on the agency’s most recent priorities. Example: Increase the total number of employees who are trained in the Incident Command System, which helps the agency respond to emergencies.

Key center director measures - Center-specific measures that are applicable to each center and are central to the Center’s priorities and strategic goals. Example: Increase FDA’s technical guidance by increasing the number of technical publications drafted, which enables the centers to better prepare industry and consumers.

Program measures - Program office-specific measures that are applicable to the office and reflect work important to the public and to FDA’s mission. Example: Monitor 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. Performance for Key Projects is measured through achievement of the stated milestones within the project’s plan. Example: 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,” said FDA Commissioner Margaret Hamburg, MD.

Related Videos
© 2024 MJH Life Sciences

All rights reserved.