NDMA suggests resolution of OTC labeling issues prior to NDA "approvable" stage.
This article was originally published in The Tan Sheet
Executive Summary
OTC LABELING ISSUE RESOLUTION PRIOR TO NDA "APPROVABLE" STAGE is recommended by the Nonprescription Drug Manufacturers Association in Aug. 16 comments on FDA's recent draft guidelines for OTC NDA and Rx-to-OTC switch procedures. The draft manual of procedures and practices (MaPP) is an attempt to formalize and create a reference point for the agency's OTC review policies ("The Tan Sheet" July 29, p. 15).