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 Their responses will help shape a new draft guidance, according to the agency.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.

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