USA – Bridging for Drug-Device and Biologic-Device Combination Products

This guidance provides recommendations to industry and FDA staff on how to approach
bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug device and biologic-device single entity or copackaged 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…