The Food and Drug Administration is making as much as $1 million in grant funding available for mining a large database of electronic health records to conduct postmarket surveillance of drug safety.
The FDA’s Center for Drug Evaluation and Research (CDER) will award a one-year grant by summer to a single bidder to develop “new analytic methodologies” to look for signs of pharmaceutical-related safety problems in the Mini-Sentinel Distributed Database, an FDA-funded pilot with access to 178 million medical records.
According to the grant announcement, the winner will support the Innovations in Medical Evidence Development and Surveillance (IMEDS)-Methods program, which “aims to improve the tools for conducting post-marketing safety surveillance using automated healthcare data and to foster their adoption.” IMEDS-Methods is a program of the Reagan-Udall Foundation, an independent, not-for-profit entity created by Congress to assist the FDA in the areas of regulatory science and research. Only members of the Reagan-Udall Foundation are eligible for this grant.
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IMEDS-Methods, according to the FDA, is “uniquely positioned to develop the new methodologies required for FDA to conduct effective active postmarket safety surveillance of medical products using large electronic healthcare data.”
Applications are due June 15. The FDA said it expects to award the grant by July 15.
