Drugs intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. The Food and Drug Administration has the broad mandate under the Federal Food Drug and Cosmetic Act to assure the safety and effectiveness of animal drugs and their use in all animals, including farm animals. Before FDA formally approves an animal drug, the sponsor or manufacturer of the drug must show in its premarket approval application that the drug is "safe and effective" in scientific testing. Such testing data, included with the application, must demonstrate a methodology to detect and measure any residue left in edible animal products and show that edible animal products when ready-to-eat are free from unsafe residues. Farmers and veterinarians treating farm animals must adhere to any restrictions about withdrawal times, or any warning or use constraints stated on the drug label.
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