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 Their responses will help shape a new draft guidance, according to the agency.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