Issue Date: December 19, 2019
Issued by: Center for Drug Evaluation and Research
Topic(s): Combination Products
Status: Draft
Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for Industry
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
Download the Guidance Document
