Mini-Sentinel Expanding Drug Safety Efforts To Prospective Surveillance
The effort will complement the FDA-funded project’s existing ability to retrospectively measure exposure to products and then analyze specific adverse outcomes.
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Known as PROMPT, the prospective monitoring system might be useful in tracking a new drug that is part of a category in which a safety issue has arisen before, or in cases where potential problems surfaced in development studies, according to researchers.
FDA’s Janet Woodcock used her time at a conference on biomedical innovation to highlight ways to use FDA’s Sentinel network more broadly to standardize, and hopefully streamline comparative effectiveness research.
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.