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  1. Transparency

FDA-TRACK: Center for Drug Evaluation & Research - Post-Approval Safety Monitoring - Compliance Dashboard

FDA-TRACK: Center for Drug Evaluation & Research - Post-Approval Safety Monitoring - Compliance Dashboard

FDA-TRACK CDER Home

FDA-TRACK is FDA's agency-wide performance management program that monitors, analyzes and reports key performance data and projects for FDA's program offices and cross-cutting initiatives.

FDA has established a wide array of guidance and regulations to help assure patients have access to high-quality over-the-counter and prescription medications that are safe and effective. CDER diligently works to ensure compliance through facility inspections, product testing, and other pre- and postmarket actions, including enforcement actions, in the United States and globally. This work includes oversight of clinical trials, commercial manufacturing of raw and finished products, compounded drugs, supply chain integrity, drug recalls, product labels, drug registration and listing, and post-market safety requirements.

For a complete list of CDER measures and their relevant FDA-TRACK dashboard, refer to the FDA-TRACK CDER Index.

To print the dashboard contents, click on the "PDF / Print Version" button below the dashboard.

 


Footnotes:

  1. For the Form FDA 483 measures, CDER began collecting data in FY18 Q2 based on ORA postings.
  2. The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" or “Archived” may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK. The data presented in the visualizations above can be accessed by clicking on the link labeled "Download Compliance Dataset" located right below the visualizations. 

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