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Veterinary Documents

Drugs for use in animals fall under the jurisdiction of the Center for Veterinary Medicine within the FDA. The approval process for New Animal Drug Applications (NADAs) closely parallels that developed for human drugs (NDAs), and requires that manufacturers prove the safety and effectiveness of products designed for use in animals. While the actual NADA is not available under the Freedom of Information Act, a Freedom of Information Summary, describing the pre-marketing studies, is generally available along with the approval letter, package insert, and labeling.

View sample pages from a veterinary FOI Summary

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