Data Integrity’s New Price Tag: How Compliance Failures Now Move Stock Prices in Hours
At 9:15 a.m. Mumbai time, Nov. 6, 2015, a single document changed billions in market…
FDA
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 –…
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…
Unmet Opportunities: Analyzing the FDA List of Drugs Without Approved Generics
The FDA’s Off-Patent, Off-Exclusivity Drugs without an Approved Generic list highlights pharmaceutical products that are…
505(b)(2): The Fast Track to Innovation in Pharma
Connecting the Past and Future of Drug Development 505(b)(2): Towards the Future, While Reflecting the Past While…