TEAs Fail To Sweeten OTC Monograph Process, Brew Trouble For New Ingredients
This article was originally published in The Tan Sheet
Executive Summary
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.
You may also be interested in...
FDA Faults BASF Sunscreen Ingredient Data In Latest TEA Rejection
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.
FDA Urged To Change OTC Monograph System, But Not In Midstream
“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.
US FDA ‘Punt’ On Hemp Rulemaking Frustrates, Confuses Supplement Industry
Industry trade groups say FDA decision against starting rulemaking for lawful use of hemp ingredients is not only overdue but failed to clear the air for businesses making or using the ingredients.