15/16 February 2024
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:
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Please also see the Draft Guidance "Requesting FDA Feedback on Combination Products - Guidance for Industry and FDA Staff" for more details.