Lachman Consultants Blog Rx to OTC Switches: New MaPP Provides Guidance and FDA Internal Policy

New MaPP 5200.11 (here) provides an outline of internal FDA policy applied when an NDA product makes a full OTC switch. A partial OTC switch means there is a "leave behind" indication in the NDA product that still requires a prescription. This can be a use, a dose, or a related disease state. This MaPP [...]The post Rx to OTC Switches: New MaPP Provides Guidance and FDA Internal Policy appeared first on Lachman Consultant Services, Inc..