The FDA released a new draft guidance that lays out a step-by-step process for applying data from a previously approved drug delivery system to an application for a combination product — a practice commonly known as bridging.
The guidance seeks to help sponsors establish the scientific relevance of data from their earlier phases of drug development or another development program that can support an NDA or BLA for a prescription or non-prescription combination product.
The FDA provides three case studies to illustrate how such data could be used. The first example is carrying over data from an IND for a drug developed in a prefilled syringe to a drug developed in an auto injector. The second case is taking data from a completed phase 3 trial of an autoinjector prototype that has not yet been submitted in an NDA and applying it to another prototype for the same drug. The third case study involves bridging data from a product that employs the same delivery device but with a different drug.
The guidance says that bridging data may be challenging or not possible with some combination products because they contain complex constituent parts and/or are likely to be affected by seemingly minor changes.