USFDA issues draft guidance on bridging data for combination products

US FDA issued a draft guidance in regards to how drug-device and biologic-device combination product sponsors can bridge data from earlier stages or development or other development programs to support an application.

The 14-page guidance gives a detailed explanation on how sponsors are able to derive an analytical framework for the identification of information gaps that could be addressed with bridging. It also provided 3 concrete examples for references.

This guidance is scheduled for finalization by the end of 2022.

More details on USFDA website: