FDA outlines industry-focused ambitions as Mini-Sentinel graduates

Center for Drug Evaluation and Research Director Janet Woodcock

Having grown to include data from 178 million patients during its 5-year history, the FDA's active safety surveillance system Mini-Sentinel has now graduated into a fully fledged program. And the FDA is already planning future iterations of the technology, including a possible industry-focused offshoot to support drug development and quality improvement.

Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, outlined the agency's plans for the system in a blog post. In the near term, the FDA is focused on refining the methods it uses to assess data, but it has more far-reaching ambitions for when the fundamentals of the system are in place. Woodcock views Sentinel as a "potentially valuable national resource" for safety researchers outside the FDA and is incorporating this idea into the system's long-term development road map.

Timelines and details are sketchy at this stage, but at some point in the future the FDA wants to work with other scientific groups to open up Sentinel to third parties. In this scenario, the FDA would give other government agencies, academics and industry researchers access to Sentinel to facilitate medical product research, quality improvement and other initiatives. Woodcock sees such access as a way to incentivize groups outside the FDA to provide financial backing and other support to help Sentinel grow.

The opening up of Sentinel could also further its primary goal--to serve the public health. The FDA applied Mini-Sentinel to questions about the safety of Boehringer Ingelheim's blood thinner Pradaxa and other products during its 5-year pilot program. Multiple safety assessments are ongoing at the time of the transition from Mini-Sentinel to Sentinel and will continue unaffected by the change.

- read the blog post

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