Annual Forecast for Planned Monograph Activities

https://dps.fda.gov/omuf/forecast?utm_medium=email&utm_source=govdelivery On September 2, the FDA announced it has released the 2025 Annual Forecast for OTC monograph activities. The over-the-counter (OTC) monograph annual forecast is a nonbinding list, issued each year, of planned monograph activities that FDA intends to initiate over the ensuing three years. These activities will generally include expected FDA-initiated proposed administrative orders (proposed orders) to add, remove, or change generally recognized as safe and effective (GRASE) conditions for OTC drug monographs including GRASE determinations for drugs marketed under 505G(a)(3) of the Federal Food, Drug and Cosmetic Act. Planned monograph activities may also include expected requests for data on specific topics to help inform future monograph activities.