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.…
FDA
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…