Cracking Down on Orphan Drug Abuse: The ORPHAN Cures Act and Its Impact
Orphan Drug Profits vs. Patients: The Orphan Drug Act of 1983 was meant to encourage…
Regulatory
Regulatory cases and compliance events that reveal how oversight works in practice — and what it means for companies, supply chains, and patients.
Britain’s Big Pharma Showdown: NHS Drug Levy Sparks £11 Billion R&D Exodus Threat
LONDON, June 4, 2025 – A storm is brewing between the UK’s National Health Service…
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…
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…