FDA opens kimono on agency performance

The FDA is furthering its journey toward transparency with the launch of FDA-TRACK, a multi-level performance management system. "TRACK" stands for transparency, results, accountability, credibility and knowledge-sharing.

The idea is to encourage agency accountability by measuring how well managers and employees meet their goals. In addition, the system provides a way for the public to monitor agency activities.

FDA-TRACK analyzes performance at four levels: Agency, center, program and project. At the center level, for example, it measures the regulator's attempts to offer guidance by tracking the number of technical publications drafted. A program-level example involves monitoring the percentage of 510(k) decisions that meet the 90-day Medical Device User Fee Act goal. And project-level performance is tracked via achievement of stated milestones.

Performance measurement stats are reported monthly; the monthly stats are analyzed quarterly and presented to leadership. The FDA-TRACK Internet site provides public access to program- and project-level activities.

- see the release
- here's the FDA-Track Internet page


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.