FDA inspections don’t arrive with much ceremony. There’s no buildup—just a badge, a few introductions, and then a steady stream of questions about your documents,
What They Are, How to Avoid Them, and How to Mitigate Successfully
On March 11, 2026, the U.S. Food and Drug Administration (FDA) announced the launch of the Adverse Event Monitoring System (AEMS), a centralized, AI-driven platform
(Yes, it’s that time of year again — compliance season!)
The Ongoing Impact of the Government Shutdown on FDA and Regulated Industry — and What Companies Should Prioritize
A Transformative Shift for Regulated Imports
The FTC’s July 2025 Crackdown on “Made in USA” Claims Puts Industry on Notice
FDA Announces Expanded Use of Unannounced Foreign Inspections
