Bridging for Drug-Device and Biologic-Device Combination Products
Title:
Bridging for Drug-Device and Biologic-Device Combination Products
Origin/Publisher:
FDA
Document Type:
Daft Guidance
Content:
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.