Tuesday, April 2, 2024

“Approved by FDA” is mandatory on most labeling components for approved animal drugs-FDA says

 On Monday, the FDA put out an update to stakeholders and a separate letter to veterinarians informing them that the statement “Approved by FDA” is mandatory on most labeling components for approved animal drugs. As required by amendments in the Animal Drug User Fee Act and Animal Generic Drug User Fee Act of 2018, the labeling statement is intended to help veterinarians, food animal producers, pet owners, and others clearly identify approved animal drugs and distinguish them from unapproved ones. The FDA’s approval ensures that the drug is safe and effective for its intended use, properly labeled, and manufactured according to current good manufacturing practices for animal drugs.