FDA wants feedback on combination products guidance
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 Their responses will help shape a new draft guidance, according to the agency.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The draft guidance describes: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 You can read the draft guidance and submit comments here.