Reinventing OTCs: FDA Seeks New Models; Stakeholders Urge Renewed Focus
This article was originally published in RPM Report
Executive Summary
FDA convened a two-day hearing to solicit new ideas to replace the OTC drug monograph system as part of a broader look at ways to enhance the regulatory model for OTCs. However, the architects of the process strongly urged FDA not to overhaul the system – but instead focus more attention on it. At stake is whether FDA makes an all out push to increase OTC switches in coming years.