Currently, adverse drug event reporting is voluntary, resulting in probable underreporting and skewed data, according to a report from the Regulatory Affairs Professional Society. However, more complete, reliable data may be available now that the majority of healthcare providers have adopted EMR systems.
An FDA posting on the Federal Business Opportunities website states the agency is seeking a contractor to develop a database to provide “continued access to a longitudinal patient-level EMR data.” The proposed database would give the FDA access to millions of records, allowing the agency to track adverse events in conjunction with demographic data, medical histories and other risk factors to gain a better understanding of the potential outcomes of drugs currently on the market.
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