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…
