PDUFA VI: FDA Proposes Expanding Sentinel, Real-World Safety Data Sources

Growth of post-market surveillance system also may require more resources.

FDA wants to widen the Sentinel system search net for drug safety signals with its integration into the post-marketing surveillance system.

As part of the prescription drug user fee reauthorization, the agency also wants to explore new real-world safety data sources, including social media, as part of a wider effort to...

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