Find here all our blog posts tagged with: EMA.

Rows of archived clinical trial samples in cold storage, with one vial illuminated as if being re-examined by new analysis.

The Next Regulatory Question Isn't the Model. It's the Data It Rescued.

AI-driven reanalysis of failed clinical trials is producing new evidence outside the systems built to validate it, and GxP quality frameworks have not caught up.

Two blank-faced clocks set at different times facing each other in a sterile laboratory corridor, symbolizing divergent regulatory timelines.

EMA Moved First on AI. FDA Is Still Deciding How.

EMA's lifecycle-wide AI reflection paper and FDA's still-open genAI device rulemaking are running on different clocks, and neither is finished business for regulated buyers.

A clock partially submerged in water with its gears exposed, symbolizing a regulatory deadline that has moved but not disappeared.

The EU AI Act Extension Is a Delay, Not a Reprieve

The Digital Omnibus pushes the EU AI Act high-risk deadline for medical devices to August 2027, but MDR/IVDR and EMA already require the same work now.