Regulatory Sciences
FDA Adds Bemotrizinol to OTC Sunscreen Monograph: What the New GRASE Determination Means for Manufacturers
On June 10, 2026, FDA issued a final administrative order (OTC000039) amending the OTC monograph for sunscreen drug products to include bemotrizinol as a generally recognized as safe and effective...
Medical Information
The Strategic Importance of a Consumer Health Service Line
In today's rapidly evolving healthcare landscape, Consumer Health brands face growing expectations to provide timely, accurate, and accessible support directly to their consumers. From nutritional...
Rethinking the OTC Monograph System
When the OTC drug review was undertaken in the 1970s, it was deemed the best solution available at the time for efficiently assessing the safety and efficacy of the countless drug products being sold...