Serious 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], Serious Averse Dug Experience “s an adverse event that is fatal, or life-threatening, or requires professional intervention, or causes an abortion, or stillbirth, or infertility, or congenital anomaly, or prolonged or permanent disability, or disfigurement.”