FDA grant to determine drug safety through EHRs
The FDA is offering a grant to turn EHR data into usable figures highlighting postmarket risks of various drugs. The agency wants to be able to perform continuous risk/benefit assessments of drugs after they hit the market, according to FDANews.
Eligibility for the grant, which will be up to $1 million, 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 EHRs as part of the Mini-Sentinel project, a pilot project to create an active surveillance system to monitor the safety of FDA-regulated medical products. With about 150 million patient records accessible online, the agency is hoping the foundation will develop analytical processes that can turn that raw data into clear safety trends.
Applications are due by June 15 and the one-year grant period will begin one month later.