Module 18 - Drug Device Combinations and Other Technologies

07/12/2023

China – the latest Human Factors needs What is different about China?

 How they use DDCP’s can differ than elsewhere.

 The population is anthropometrically different.

 The population is culturally different.

 The population sees healing and therapy differently.

 The attitudes of the population to healthcare is different.

 The population is the largest in the world >1.425bn.

 There are different economics in China.

 There are different data restrictions in China.

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

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US FDA - ANDA – A new drug application! When you have a new drug product that includes a device, then a comparative human factors study is required – to compare the existing drug device combination product with what the new drug application includes. An example of this would be when a generic drug device combination product is going through a US FDA regulatory submission.  A Comparative Human Factor Study is based upon Non-Inferiority.  The Study sample size is typically 50-150 participants per user group!  The Study has to be performed in the USA with US people.  The Study has to show that the new drug device combination product performed better than the existing.

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

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