For Successful OTC Switch Proposals, A Good Offense Defends Against Doubters
Executive Summary
OTC switch sponsors should identify adversaries early in the application switch process so they can counter arguments that could derail their switch, s consultant advises. Some switches fail because firms target regulatory approval and do little on marketplace performance.
You may also be interested in...
Sensitivity To Flu Helped OTC Drug Firms End 2017 With Sales Boost
Cold and flu products performed “extraordinarily strong” wherever an influenza virus hit hardest, demonstrating “how understanding key incidents can really help tactical support and trade strategies at the local level,” market researcher says at CHPA exec conference.
Sensitivity To Flu Helped OTC Drug Firms End 2017 With Sales Boost
Cold and flu products performed “extraordinarily strong” wherever an influenza virus hit hardest, demonstrating “how understanding key incidents can really help tactical support and trade strategies at the local level,” market researcher says at CHPA exec conference.
OTC Switches Face Tougher FDA Evaluations, Less Predictable Process
OTC switch sponsors bear more responsibility than in previous years to convince FDA a product would be safely used and has a strong risk/benefit profile, say Pinney Associates consultants. FDA currently is more conservative on risk/benefit decisions and the advisory committee process isn't productive, they say.