FDA - AER

For the Federal Drug Administration's (FDA) post-marketing surveillance program, ZAI's medical staff and records specialists review adverse event reports and perform medical coding using the Medical Dictionary for Regulatory Activities (MedDRA) to code adverse events related to human drugs and the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) to code reports concerning veterinary medicinal products. FDA uses this critical information to identify safety concerns related to marketed products and to evaluate manufacturers' compliance with reporting regulations.