Search Results for: Rx-to-OTC Switch

Successful Rx to OTC Switch Depends on Responsiveness to FDA and Other Stakeholder Issues of Concern, Early and Integrated Commercial Planning

Christine Sweeney and George Quesnelle FDA approval of an Rx-to-OTC switch depend on anticipation of issues likely to be raised by FDA division and nonprescription staff, as well as other policy stakeholders.  Commercial success following approval similarly requires addressing issues even before submission and looking beyond FDA approval. “Rx-to-OTC switch is not a regulatory check-box... Read more »... Read More >