US FDA, Drug-device and biologic-device combination product sponsors bridging data draft

US, FDA issued a draft guidance in regards to how drug-device and biologic-device combination product sponsors can bridge data from earlier stages or development or other development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

https://www.fda.gov/media/99140/download