Unexpected Adverse Drug Experience [Food and Drugs] Law and Legal Definition

Pursuant to 21 CFR 514.3 [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter E Animal Drugs, Feeds, and Related Products; Part 514 New Animal Drug Applications; Subpart A General Provisions], Unexpected Adverse Drug Experience “is an adverse event that is not listed in the current labeling for the new animal drug and includes any event that may be symptomatically and pathophysiologically related to an event listed on the labeling, but differs from the event because of greater severity or specificity. For example, under this definition hepatic necrosis would be unexpected if the labeling referred only to elevated hepatic enzymes or hepatitis.”