Key Takeaways
- The FDA plans to focus on meeting existing mandates for its Sentinel surveillance system, rather than adding new capabilities.
- CDER Director Patrizia Cavazzoni attributed the decision to funding issues, saying the program had to be responsive to “the realities of our budgets.”
- Ideally, the program will be able to scale up when needed, such as during the COVID-19 pandemic, Cavazzoni said.
The US Food and Drug Administration is adjusting expectations for its Sentinel drug safety monitoring system to adapt to the “hard truth” that reliable funding is not assured.
Center for Drug Evaluation and Research Director Patrizia Cavazzoni delivered the message in opening remarks during the 16th annual Sentinel workshop, which was hosted for the agency by Duke Margolis...