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Goodbye FAERS? FDA launches new combined adverse event database
System will replace safety databases monitoring drugs, devices, food, and more ...
On March 11, the FDA launched a unified platform for analyzing adverse event reports, replacing a fragmented infrastructure that had long-impeded effective postmarket surveillance.¹ Known as the FDA ...
After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance aims to standardize the practice. But recent decisions call into question ...
On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major barrier to the use of real-world evidence (RWE) in medical device ...
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