TEAs Fail To Sweeten OTC Monograph Process, Brew Trouble For New Ingredients
This article was originally published in The Tan Sheet
The TEA option has not provided a more efficient and less costly method for drug industry stakeholders to convince FDA to expand OTC monographs with ingredients that have demonstrated safety records in foreign markets, but a system that rivals the rigors of the new drug application process.
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FDA advises BASF that the information the firm submitted is not sufficient to establish octyl triazone as GRASE. The agency’s third rejection this year of a sunscreen TEA could concern advocates on Capitol Hill and in the industry for using the process for adding ingredients to the OTC sunscreen monograph.
“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.