New CDER Conversation: Studying how pathogens cause disease- Drug Information Update

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The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

Talking with Daniela Verthelyi, Chief, Laboratory of Immunology, Office of Biotechnology Products, Office of Pharmaceutical Quality, CDER

In order to effectively regulate products that diagnose, treat or prevent infectious diseases, scientists and reviewers in the Center for Drug Evaluation and Research must understand the bacteria, viruses, and parasites that cause diseases. Scientists in CDER conduct many programs to advance regulatory science and research on pathogens -- agents that cause infection or disease. There are many pathogens being studied at CDER’s Office of Biotechnology Products – from food and blood-borne bacteria, to infections caused by parasites, and viruses such as the Zika virus. CDER is charged with advancing public health through the review, regulation, and research of potential treatments. How does the study of bacteria and viruses help drug development and review? Let‘s explore.

For more information please visit: Pathogens