Day: June 25, 2026

In the high-stakes arena of medical device clearance, a single compromised data point can dismantle years of costly research and development. Recent FDA alerts targeting third-party testing laboratories in China have sent shockwaves through the global medtech industry, revealing widespread fabrication of critical performance data. While it is tempting to view these external laboratories as … Read more

The FDA’s newly minted June 2026 guidance, Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products, reads like a regulatory dream. It outlines a world where a single, stellar trial paired with smart confirmatory evidence can win an approval. But experienced sponsors know that what is penned by leadership at the top of the agency often … Read more