Claudia Manzo, PharmD
Director, Office of Medication Error Prevention and Risk Management, OSE, CDER
Claudia Manzo, PharmD is the Director of the Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology (OSE), in FDA’s Center for Drug Evaluation and Research. She has over 20 years of drug safety experience and in her current role she directs review staffs that are the CDER leads for the review Risk Evaluation and Mitigation Strategies (REMS), REMS assessments, REMS modifications, proprietary names, human factors studies, and medication errors for drugs and biologic products regulated by CDER. She has also coauthored several regulatory guidance documents for industry including Development of a Shared System REMS.