FDA Offers Combination Product Guidance on Bridging Data for NDA, BLA Applicants

December 26, 2019

The FDA released a new draft guidance that lays out a step-by-step process for applying data from a previously approved drug delivery system, a practice commonly known as bridging, to an application for a combination product.

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.

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