Draft FDA Guidance Concerning Combination Products

By Ann Leonard

As those working in the development of combination products likely know, the Food and Drug Administration (FDA) issued two new draft guidances in December 2019. The guidances – Requesting FDA Feedback on Combination Products and Bridging for Drug-Device and Biologic-Device Combination Products– were published in response to the 21^st Century Cures Act and Prescription Drug User Fee Act VI, respectively.

The two documents clarify best practices for communication during interaction with the agency and provide a framework for identifying gaps in development programs that may result from the unique properties of the combination product despite well-known constituent parts. Complex generic combination products often use or require new chemical formulations and/or delivery methods.