Docket Number:
FDA-2019-D-5585
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Office of the Commissioner, Office of Clinical Policy and Programs, Office of 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

 

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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-5585.

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