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# ‘Negative Controls’ and Real-World Evidence Workshop
- URL: https://www.fdaweb.com/negative-controls-and-real-world-evidence-workshop/
- Published: 2023-01-17T12:00:00.000Z
- Updated: 2026-09-14T18:11:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153552

FDA is announcing a 3/8 workshop entitled “Understanding the Use of Negative Controls to Assess the Validity of Non-Interventional Studies of Treatment Using Real-World Evidence.” The workshop, which is mandated by the current drug user fee agreement, will be hosted by the Duke-Margolis Center for Health Policy.

The [event](https://healthpolicy.duke.edu/events/exploring-utility-negative-controls-causal-inference-sentinel-initiative?ref=fdaweb.com) is intended to discuss existing negative control methodologies for real-world data studies, and outline advantages and disadvantages for using negative controls to evaluate medical product safety and effectiveness. Additionally, CDER/CBER will propose projects to develop negative control methods and implement new tools for use in the Sentinel System’s, Biologics Effectiveness and Safety System.