FDA starts real-time reporting of adverse event data

The US Food and Drug Administration on Friday revealed it has begun daily publication of adverse event data from the FDA Adverse Event Reporting System (FAERS).

This represents a significant step forward in modernizing the agency’s safety monitoring infrastructure and demonstrates its commitment to radical transparency and real-time protection of public health.

“Adverse event reporting should be fast, seamless and transparent,” said FDA Commissioner Dr Marty Makary, noting that “people who navigate the government’s clunky adverse event reporting websites should not have to wait months for that information to become public. We’re closing that waiting period and will continue to streamline the process from start to finish.”