Innovating Outside OTC Monograph Lines: Trending Acne Patches, Hand And Foot Antiperspirants
Executive Summary
Industry and the FDA agree that the OTC drug monograph system is direly in need of reform, but innovating with noncompliant dosage forms and indications, without approved new drug applications, is a risk companies need to weigh seriously, says Arnall Golden Gregory partner Alan Minsk. The FDA offers perspective on its OTC monographs for acne and antiperspirant products.