Phase III Could Be Replaced With “Targeted Approval” – Manhattan Institute
Executive Summary
The need for Phase III clinical trials would be reduced if sponsors use validated biomarkers in Phase II studies under a Manhattan Institute proposal
You may also be interested in...
Novartis Proposes Two-Phase Drug Development Model, Staged Approval
Novartis is advocating a two-phase drug development paradigm based on "models of disease.
Warfarin Dosing Biomarkers Could Be Model For Genetic Tests In Labeling
The development of standards for a warfarin dosing biomarker under a collaboration with the C-Path Institute could pave the regulatory pathway for markers involving other therapeutic agents
Drugs Should Get Longer Patents In Exchange For More Safety Data – Wood
Offering extended exclusivity, in advance, for drugs that address an unmet medical need could bring a necessary boost to research and development efforts, Vanderbilt University's Alastair Wood said