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U.S. Department of Health and Human Services

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Can you explain the approval process for animal drugs?

Like all human drugs, a new animal drug has to be approved by FDA before it is sold and marketed to the public. And like the human drug approval process, the new animal drug approval process is complicated. Before a new animal drug may receive FDA approval, the drug sponsor must demonstrate that the new animal drug product is safe and effective when used as directed on the label. Drug sponsors submit to FDA a New Animal Drug Application (NADA) along with supporting data, including all unexpected side effects (adverse effects) associated with the drug product’s use. The drug sponsor must show that it can manufacture the drug product so that the product’s composition is consistent from batch to batch, that the product’s active ingredients come from reliable sources, and that it follows good manufacturing practices while making the product. If the drug product is to be used in a food-producing animal, residues in food products (such as meat and milk) from that animal must be shown to be safe for human consumption.

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