Inactive

The primary objective of this project is to conduct multiple CUHF studies of complex drug-device combination products in relevant populations (e.g., patients and/or caregivers and/or health care provi... The primary objective of this project is to conduct multiple CUHF studies of complex drug-device combination products in relevant populations (e.g., patients and/or caregivers and/or health care providers) to assess the impact of “other” design differences between the user interfaces of an RLD and existing or potential generics referencing the RLD. See Attachment for Detailed RFP. See attachment for Contractor's questions and Government responses.