MyChesCo on MSN

FDA launches real-time safety database for drugs and vaccines

WASHINGTON, D.C. — The U.S. Food and Drug Administration has launched a new centralized system that will allow scientists, ...
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After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance ...
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 ...
JD Supra

FDA Issues Updated Guidance on Expanded Access to Investigational Drugs

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 ...
The American Journal of Managed Care

Global Gaps in Drug Access After FDA Approval: Insights From New Study and Ethics Guidelines

Lower-income countries rarely gain timely access to FDA-approved drugs tested in their populations, highlighting major global and ethical disparities. Physical access was defined as where a tested ...