USA: FDA Drafts Guidance on Bridging Data for Combination Products

The US Food and Drug Administration (FDA) released draft guidance on bridging information on products featuring different combinations of drug-device and biologic-device combination products.

The draft guidance can assist the sponsors to establish the scientific significance of data from their earlier phases of drug development or another development program that can support an New Drug Applications (NDAs) or biologics license applications (BLAs) for a prescription or non-prescription combination products including the following: 

• Bridging of information related to a combination product that employs a different device constituent part or parts with the same drug constituent part or parts as the proposed combination product
• Bridging of information related to a combination product that employs a different drug constituent part or parts with the same device constituent part or parts as the proposed combination product

This guidance seeks to clarify how to bridge to information gathered from another development program to leverage that information in support of an application. To facilitate that process, this guidance describes an approach for an applicant to identify and address information gaps for an application.

The three examples provided in the guidance follow the stepwise approach and include:

• Bridging within an IND from a drug developed in a prefilled syringe to a drug developed in an autoinjector;
• Bridging from one autoinjector (prototype 1) to another autoinjector (prototype 2) from the same drug; after Phase 3 studies have been completed but before NDA submission; and
• Bridging data from a combination product that employs the same device combined with a different drug.

FDA is accepting feedback on the combination product communication draft until Feb. 24 and the comment period closes on Feb. 18.