One clinical trial/one actual-use study approach to OTC trials suggested by FDA consultant.
This article was originally published in The Tan Sheet
Executive Summary
Rx-TO-OTC SWITCH NDAs: ONE CLINICAL TRIAL/ONE ACTUAL-USE STUDY SUGGESTED by FDA consultant Bernard Schachtel, MD, as a possible alternative to the requirement of two adequate and well-controlled clinical trials for Rx-to-OTC switch applications. Speaking at the Nonprescription Drug Manufacturers Association's annual R&D conference on Sept. 13 in Washington, D.C., Schachtel discussed "innovative approaches" to six issues relevant to OTC clinical trials.