The FDA is seeking comment from sponsors of combination products on how they want the agency to respond to their scientific and regulatory questions. Their responses will help shape a new draft guidance, according to the agency.
The FDA defines a combination product as one composed of any combination of a drug, device and/or a biological product. It assigns each application for a combination product to “lead center” from among its centers for Devices and Radiological Health, Biologics Evaluation and Research and Drug Evaluation and Research.
The draft guidance describes:
- Best practices for the agency and for combination product sponsors.
- Information to include when requesting agency feedback on a combination product.
- Feedback mechanisms.
- Combination product agreement meetings.
Deadline for submitting comments is Feb. 24, 2020. You can read the draft guidance and submit comments here.