Nitrosamines 2.0: new AI thresholds, new “casualties,” and finally predictable rules
The story really does begin in a hot stretch of 2025, when three regulators –…
EMA
Paper Cuts: Dossier Mistakes That Stopped Big Drugs Cold
Introduction: Nothing stings quite like a regulatory refusal in the high-stakes world of drug development.…
Gaming Generic Drug Approvals: Legitimate Loopholes and Illicit Tactics
Introduction: Generic drugs and their global counterparts are meant to break monopolies and drive down…