Tag: AI in PV

The FDA’s transition is nearly complete. As of April 1, 2026, all premarketing IND safety reports must utilize the E2B(R3) standard. We are now in the final countdown for postmarketing ICSRs; starting October 1, 2026, the FDA will move exclusively...

Every minute, somewhere in the world, an adverse event report is being filed. EudraVigilance alone collected and managed 1,765,581 Individual Case Safety Reports (ICSRs) in 2025, taking its cumulative post-authorisation total to over 29 million reports since 2002.Across the Atlantic,...