Day: March 19, 2026

The FDA’s transition to the Adverse Event Monitoring System (AEMS) represents a fundamental shift from fragmented legacy databases to a centralized, cross-center regulatory architecture. This modernization effort consolidates disparate reporting streams for drugs, biologics, and medical devices into a singular analytical interface designed to enhance signal detection and data accessibility. For industry leadership, this evolution … Read more

The FDA’s long-anticipated transition toward human-centric predictive toxicology has reached a pivotal milestone with the release of the March 2026 draft guidance on New Approach Methodologies (NAMs). This document provides the high-level validation framework necessary for sponsors to move away from legacy animal dependencies and toward scientifically robust, in vitro and in silico alternatives. For … Read more