OTC REVIEW's EXPECTATIONS FOR EFFICACY IN SWITCHES MAY IMPLY HIGHER STANDARD
This article was originally published in The Tan Sheet
Executive Summary
OTC REVIEW's EXPECTATIONS FOR EFFICACY IN SWITCHES MAY IMPLY HIGHER STANDARD for such products versus prescription drugs, FDA Office of Drug Evaluation I Director Robert Temple, MD speculated at the Nonprescription Drug Manufacturers Association Research & Scientific Development Conference on Oct. 19. Temple hypothesized that "there is a different expectation" and perhaps a "higher standard" for "how effective an over-the-counter drug should be compared to a prescription drug" due to definitions for effectiveness found in OTC drug monograph regulations.