FDA Announces FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA

The U.S. Food and Drug Administration announced in the Federal Register today the fiscal year 2019 rates and payment procedures for animal drugs subject to user fees under the Animal Drug User Fee Amendments of 2018 (ADUFA IV) and Animal Generic Drug User Fee Amendments of 2018 (AGDUFA III). ADUFA, originally signed into law in 2003 and reauthorized in 2008, 2013 and 2018, amends the Federal Food, Drug, and Cosmetic Act and authorizes the FDA to collect fees for certain animal drug applications and supplements, products, establishments, and sponsors of animal drug applications and/or investigational animal drug submissions. These resources support the FDA’s responsibilities to ensure that new animal drug products are safe and effective for animals, as well as ensuring the safety of food from treated animals. ADUFA IV reauthorizes the FDA to collect user fees through FY 2023.