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BioCommunique Article

Submit concerns for Bridging for Drug-Device and Biologic-Device Combination Products draft guidance and on scientific and regulatory questions during developme

Provide Feedback on FDA Combination Products Draft Guidances

  • 2020-01-31T16:54:00.000+0000
  • Washington DC
  • Author: Brittany Blocker

In late December, the Food and Drug Administration (FDA) released a draft guidance entitled, Bridging for Drug-Device and Biologic-Device Combination Products, explaining how to approach bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug device and biologic-device single entity or packaged combination products. The draft describes how sponsors can develop an analytical framework for identifying information gaps that could be addressed with bridging and provides three examples of bridging scenarios for different drug-device combination products. The agency also released a draft guidance on requesting feedback from the agency on scientific and regulatory questions during the development of a combination product.

Biocom is requesting member feedback on both draft guidances. Some initials concerns include:

  • In the bridging draft guidance, the agency does not reference master files with information relevant to an NDA or BLA application for combo products with device constituents
  • In regards to the feedback draft guidance, there is no clarity regarding jurisdiction for convenience kits that are combination products for instances when the components did and did not undergo additional processing, such as sterilization.

The comment deadline for the bridging guidance is February 18th and February 24th for the feedback guidance. Please submit feedback to Biocom’s Manager of Regulatory Affairs, Brittany Blocker, by February 5th.