FDA/CDER Workshop Highlights

Last week I attended the sixth annual HFES International Symposium on Human Factors and Ergonomics in Health Care in New Orleans, LA, USA. The event attracted 460 attendees from industry, academia, consulting firms, government, and healthcare. The day before the symposium, the FDA gave a workshop titled, “Product Development and Human Factors Considerations: Navigating the Halls of FDA/CDER.” The workshop was given by CDER’s Quynh Nhu Nguyen, Associate Director for Human Factors, and Mishale Mistry, Acting Director. The workshop was very well organized and provided key insights into CDER’s latest thinking on the validation of combination products. It was lively and interactive with lots of q

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