USA – FDA issues draft guidance on communications with combo product developers

The 21st Century Cures Act requires FDA to provide final guidance on aspects of the submission process including how companies should obtain feedback from the agency. That requirement led to the release of draft guidance titled “Requesting FDA Feedback on Combination Products.”

In the text, FDA defines combination products as “any combination of a drug, a device, and/or a biological product” before outlining how it reviews and regulates the category.

The core of the document is focused on best practices for interactions between sponsors and FDA and the mechanisms through which the agency provides feedback on combination products. In the section on best practices for sponsors, FDA calls for developers of combination products to pose clear and appropriate questions, provide comprehensive supporting information and communicate with the agency through a dedicated point of contact.