Pharmaceutical Commerce

FDA Vowes Improved Adverse Event Reporting With AEMS

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

Why Industry Is Questioning FDA’s Data-Sharing Push in Cell and Gene Therapy

After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance aims to standardize the practice.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 ...
MedPage Today on MSN

Goodbye FAERS? FDA launches new combined adverse event database

System will replace safety databases monitoring drugs, devices, food, and more ...
JD Supra

Awash in Data? FDA Removes a Barrier in Real-World Evidence Generation

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 ...