USA: FDA Drafts Guidance on Bridging Data for Combination Products

The U.S. Food and Drug Administration (FDA) has issued draft guidance outlining how sponsors can bridge data across different development programs for drug–device and biologic–device combination products. The guidance explains how previously generated data may be used to support New Drug Applications (NDAs) or Biologics License Applications (BLAs) for both prescription and non‑prescription combination products.

Purpose of the Draft Guidance

The document is intended to help sponsors determine when data from an earlier stage of development—or from a separate but related development program—can be scientifically justified to support a new application. It describes approaches for identifying and addressing information gaps to ensure the suitability of bridging data.

Types of Bridging Considered

The FDA highlights two primary scenarios where bridging may be appropriate:

• Bridging data from a combination product that uses a different **device constituent part(s)** while retaining the same **drug constituent part(s)** as the proposed product. 
• Bridging data from a combination product that uses a different **drug constituent part(s)** while retaining the same **device constituent part(s)** as the proposed product.

These approaches allow sponsors to leverage existing information when changes are made to either the drug or device component.

Examples Provided in the Guidance

The draft includes three stepwise examples illustrating how bridging may be applied:

1. Within an IND, bridging data from a drug delivered via a **prefilled syringe** to a drug delivered via an **autoinjector**. 
2. Bridging from **autoinjector prototype 1** to **autoinjector prototype 2** for the same drug after Phase 3 studies are complete but before NDA submission. 
3. Bridging data for a combination product that uses **the same device** but incorporates **a different drug**.

Public Comment Period

FDA is accepting comments on the draft guidance until **February 24**, and the general comment period for this communication closes on **February 18**.