FDA Feedback on Combination Products

Recommendation

2/3 May 2024

Process Validation - Live Online Training

For combination products, there is a draft guideline that describes ways in which a sponsor can communicate with the FDA during the development of a combination product. What does it say?

The draft comprises 18 pages. The aim of the guideline is to outline different ways in which a sponsor of a combination product can receive feedback from the FDA on scientific or regulatory issues. This can be done through an authorisation-related mechanism, through the pre-submission process as used by the CDRH and CBER and through formal meetings with the CDER and CBER. Feedback can also be provided through Combination Product Agreement Meetings (CPAMs).

The draft guideline is divided into 4 parts:

• Part I introduces the guide
• Part II covers the background. It describes general questions about combination products, the regulation of these products by the FDA and how to contact them
• Part III describes "best practices" for the interaction between sponsor and FDA
• Part IV describes in detail the above feedback mechanisms available for combination products

Two appendices provide examples of the admission-related mechanisms depending on the centre that is primarily responsible for admission.

Please also see the Draft Guidance "Requesting FDA Feedback on Combination Products - Guidance for Industry and FDA Staff" for more details.