Introduction and Overview
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*David M Petullo, Center for Veterinary Medicine 

Keywords: Center for Veterinary Medicine, study design, sample size, power, safety, effectiveness

FDA’s Center for Veterinary Medicine (CVM) regulates the manufacture and distribution of food additives and drugs that will be given to animals. Within CVM, The Office of New Animal Drug Evaluation (ONADE) determines whether or not a “new animal drug” should be approved. Section 512 of the Federal Food, Drug, and Cosmetic Act (FFDCA) was designed to ensure that animal drugs are safe and effective for their intended uses. If the product is for use in a food-producing animal, human food safety studies must also be conducted to determine withdrawal times that will ensure that the edible animal products are free of unsafe drug residues. Studies to demonstrate effectiveness and safety at CVM employ many different experimental designs and analyses to incorporate features relevant to each particular species and its associated husbandry practices in addition to features related to the variety of indications for both companion and food producing animals.