Fda reportable ade Study guides, Class notes & Summaries

FDA-reportable ADE correct answer: For reporting an ADE to the FDA, the FDA defines ADEs as serious adverse events related to drugs or devices in which "the patient outcome is death, life threatening (real risk of dying), hospitalization (initial or prolonged), disability (significant, persistent, or permanent), congenital anomaly, or required intervention to prevent permanent impairment or damage. Reportable serious ADEs to the FDA may include: a. Phenytoin-induced toxic epidermal necrol...