To Improve Access to Data on Adverse Drug Reactions US FDA Introduces a new search tool

A new user-friendly search tool is launched by US Food and Drug Administration that can improve access to data on adverse reactions associated with a variety of different drug and biological products through FAERS (FDA’s Adverse Event Reporting System). This tool is designed to make it easier for the consumers, researchers and providers to access the information related to the adverse reactions of drugs.

Scott Gottlieb, M.D., FDA Commissioner said, “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 the drug and biologic products after they are approved by the FDA. 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 tool enables the users to search and organize the data by different criteria like drug/ biological product, patient age, type of adverse events. In addition to organizing the data, the FDA hopes that the increased transparency will spur the submission of more detailed and complete reports from consumers and healthcare professionals.

FAERS is used by FDA for surveillance such as looking for new safety concerns that may be related to a marketed product. It also helps in evaluating a manufacturer’s compliance with reporting regulations. FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research will evaluate the reports in Faers and monitor the safety of the products after they are marketed.

Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said “Our focus on safety extends beyond approval. 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 a complete reports.”


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