WASHINGTON, D.C. — The U.S. Food and Drug Administration has launched a new centralized system that will allow scientists, ...

The FDA launched AEMS, a unified platform that replaces fragmented legacy databases to enable real-time adverse event reporting.

The FDA has launched a new adverse event reporting system that will consolidate several systems it has for reporting different types of adverse events, the agency announced Wednesday. The new system, ...

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 ...

After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance aims to standardize the practice.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) has issued updated guidance on Expanded Access to Investigational Drugs for Treatment Use, clarifying how drug developers, physicians, and patients can ...