FDA Compliance
On April 2, 2026, the U.S. Food and Drug Administration issued a warning letter to Purolea Cosmetics Lab, reference 722591-04022026. By now, most of you have heard the story. The company had used AI agents to write drug product specifications, procedures, and master production records. No…
Extreme heat, drought, wildfires, floods, record-low rivers, and rising energy demand have defined much of the summer of 2026. But for businesses, the important story isn’t simply that weather records are being broken. It’s where those physical changes enter the operating system of a company.…
The European Commission’s latest Joint Actions on Compliance of Products (JACOP) project offers a useful starting point for understanding why products can still fail environmental compliance checks even when manufacturers have established compliance programs.
Published in June…
Ask a premarket team where corrective and preventive action (CAPA) sits on the priority list, and it usually lands below design controls, risk management, and the submission itself. The reasoning is easy to follow. Nothing has shipped, so there are no complaints to investigate, no returned…
Medical device companies selling into multiple countries don’t answer to one global regulator. They navigate a patchwork of national requirements that two organizations are trying to align in very different ways.
The International Medical Device Regulators Forum (IMDRF) and the…
A CEO doesn’t need to read every AI law to understand why regulation matters. It shows up in subtler ways: a sales team using a chatbot with client data, a hiring manager testing an AI screening tool, a board member asking whether the company has an AI policy. AI governance has moved from the…