Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed How to build a successful combination product program “I’m in my phase 2 clinical trial…now what?” One of the common challenges we run into in the...
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Creating A Design History File (DHF) That Gets Approval Combination products have unique design and regulatory requirements from those of drugs and...
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed What happens when you need to switch your drug delivery device mid-development? Luckily, it does not happen often. But it does happen. Your drug...
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Interpreting Drug & Device Regulations In A Changing Landscape: The Impact of Innovation and COVID-19 Technology and innovation is challenging the...
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Planning Usability Testing During COVID-19 The recent Covid-19 pandemic has changed how we are able to interact socially, and it has changed our...