FDA Urged To Change OTC Monograph System, But Not In Midstream
This article was originally published in The Tan Sheet
Executive Summary
“Moving away from the monograph system when we are so close to the end” would “risk setting back the OTC drug review many years or even decades,” CHPA head Scott Melville says at an FDA public hearing. Other stakeholder s explain how the monograph system has failed industry and consumers.
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