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Cap On Mini-Sentinel Funds Raised To $135 Mil. To Support Powerful Surveillance Resource

Funds for FDA’s Mini-Sentinel post-market surveillance program were originally capped at $100 million based on projections for a consortium of at least three automated health care data partners to build analysis capabilities for data covering 100 million patients. The project has significantly exceeded those goals.

FDA has increased the funding ceiling in its contract with Harvard Pilgrim Health Care for the Mini-Sentinel post-market safety surveillance project by $35 million to $135 million, the agency recently announced.

The increase is needed to support the larger-than-expected data resource that has been built by Harvard Pilgrim to support FDA...

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