A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and biological product. These product components can be physically, chemically or otherwise combined. 
 
 
If you believe that the product that you are developing might fall into this category, GEMAR can help you to determine:
 
 
  • the “primary mode of action” of the combination product and therefore which FDA Center will have the lead in the review

  • what type of marketing application will be required and what kind of safety and effectiveness information in is needed to support approval

  • what good manufacturing practice regulations apply to the combination product

  • how adverse events are reported for combination products

  • what are the applicable user fees for combination products

 
 
Contact us for further information.