Pre-ANDA strategy and Human Factors activities to de-risk pharmaceutical companies ANDA submission of drug–device combination products: case study of a formative Comparative Use Human Factors study

Background This article presents a strategy that a Drug Delivery Device Developer (DDDD) has adopted to support Abbreviated New Drug Application (ANDA) submissions of drug-device combination products. As per the related FDA guidance, a threshold analysis should be compiled. If 'other differences' between the Reference Listed Drug (RLD) and the generic drug devices are identified, a Comparative Use Human Factors (CUHF) study may be requested.