CDER Conversations
CDER’s Drug Quality Sampling and Testing program
CDER’s Office of Pharmaceutical Quality (OPQ) oversees the quality surveillance program. Guided by information on the State of Pharmaceutical Quality, expanding product knowledge, and the availability of more sophisticated testing methods, OPQ began to adopt a more targeted, risk-based approach to drug sampling and testing beginning in 2018. This approach has been effective in identifying more products per year that do not meet quality standards than in previous years.
In this CDER Conversation, we sit down with Jennifer Maguire, director of the Office of Quality Surveillance in OPQ to learn more about the drug quality sampling and testing program.