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Pharmaceuticals / Regulatory Affairs / Postmarket Safety

FDA Unveils $1 Million Postmarket Surveillance Grant

April 21, 2015
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The FDA is offering a grant of up to $1 million to turn large amounts of electronic health record data into usable figures highlighting postmarket risks of various drugs. The goal is for the agency to be able to perform continuous risk/benefit assessments of drugs after they hit the market.

Eligibility for the grant is limited to the Reagan-Udall Foundation through its Innovations in Medical Evidence Development and Surveillance-Methods program.

The FDA announced plans in January to build a database of electronic health records as part of the Mini-Sentinel project. There are roughly 150 million patient records online, and the agency is hoping the foundation will develop analytical processes that can turn that raw data into clear safety trends.

The endeavor should focus not only on the best uses of that data, while understanding its limitations, but also account for biases in observational studies, the FDA says.

Applications are due to www.grants.gov by June 15. The one-year grant period will begin one month later. Read the Federal Register notice at www.fdanews.com/04-14-15-postmarketresearch. — Lena Freund