The FDA has launched a single public platform for adverse event reports related to drugs, biologics, vaccines, cosmetics and animal food.
The Adverse Event Monitoring System will publish reports in real time and replace all previously used adverse event databases by the end of May, according to a March 11 news release from the agency.
The agency, which processes around 6 million adverse events per year, expects to save about $120 million and reduce the administrative burden tied to FOIA requests by consolidating reporting to one system.
The Adverse Event Monitoring System has already replaced the FDA Adverse Event Reporting System, the Vaccine Adverse Event Reporting System and the Adverse Event Reporting System. By the end of May the new system also will replace the Manufacturer and User Facility Device Experience system, the Human Foods Complaint System and the Center for Tobacco Products Adverse Event Reporting System, the release said.
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