The US Food and Drug Administration has launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS).
The tool is designed to make it easier for consumers, providers, and researchers to access this information.
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Tools like the FDA Adverse Event Reporting System are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and providers make safe use of drug and biologic products after they are approved by the FDA,’ explained FDA Commissioner Scott Gottlieb, MD.
‘The FDA is committed to fully informing patients and providers of adverse events reported with medical products and this enhanced portal now provides patients, doctors and others with easier access to the data they are interested in.’
The new dashboard enables users to search for and organise data by criteria, such as drug / biological product, age of the patient, type of adverse event, year the adverse event occurred, or within a specific timeframe.
In addition to making it easier for consumers to search for adverse events reported with drug or biologic products, the FDA hopes that the increased transparency will spur the submission of more detailed and complete reports from consumers, healthcare professionals and others, by making it easier for people to see other reports that the FDA receives, and search the database for similar observations.
‘Our focus on safety extends beyond approval,’ commented Janet Woodcock, MD, Director of the FDA’s Centre for Drug Evaluation and Research.
‘In fact, our staff spends a lot of time looking at FAERS reports received regarding approved drug and biologic products and these reports can be very valuable components of our safety assessments. By giving people a better understanding of these data, and the associated limitations, we hope the new interface will encourage people to submit more complete reports.’
