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Magnifying glass files regulatory documents GettyImages-614037306 Regulatory Attention To Human Factors: How Much Is There?

In this article, Chief Editor Tom von Gunden considers trends in drug delivery likely to drive increased scrutiny around Human Factors {HF) in regulatory submissions and approvals. In an embedded video and transcript from Tom’s conversation with combination products consultant Doug Mead, the two discuss findings from GenAI queries that surfaced FDA precedents on HF-related matters including critical tasks, use errors, and risk mitigation.  

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In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks the panel to comment on post-market regulatory considerations and processes for combination products. Among the topics covered are post-approval changes, design outputs, patient safety, and various regulatory guidances.

In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks panelist Barr Weiner to describe the role of case study examples in defining and regulating combination products globally. Weiner makes the case for agreement about the science and technology being more important than commonality in terminology, Panelist Fran DeGrazio agrees.

In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks panelist Fran DeGrazio to comment on her front-of-mind topic of systems thinking and platform approaches to combination product development.

In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden invites panelists Fran DeGrazio, Barr Weiner, and Rumi Young to identify and comment on their most important takeaways from their panel conversation. They point to platform thinking, post-market manufacturing, and the representation of combination products in regulatory guidances.

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