Yesterday, the Food and Drug Administration (FDA) announced the launch of the Adverse Event Monitoring System ( AEMS ), a new platform for assessing adverse event reports made to the FDA for drugs, ...
The FDA launched AEMS, a unified platform that replaces fragmented legacy databases to enable real-time adverse event reporting.
System will replace safety databases monitoring drugs, devices, food, and more ...
FDA launches new AI-powered system to track drug and vaccine side effects in real time, replacing outdated databases and saving $120 million annually.
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 ...
After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance aims to standardize the practice.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 ...
The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have launched two coordinated initiatives: the FDA Technology-Enabled Meaningful Patient Outcomes ...