Combination Device and Drug/Biologic Submissions

Generally speaking, a combination product is composed of any combination of a device/drug, device/biologic, drug/biologic or combination of all three, including co-packaged products. Combination products are often confused with fixed combination dose (FCD) drug products, which are comprised of drug/drug combinations. Because PDG’s team of device consultants and pharmaceutical consultants possess industry expertise in the development of drugs, biologics, and medical devices, we can help you navigate the complex array of regulatory pathways. This includes help in determining which pathways are most feasible and cost-effective and whether a single marketing application or separate marketing applications for each individual component is needed. When regulatory jurisdiction is not clear, PDG will function as your voice at the Office of Combination Products to include informal communications and/or submission of a request for designation.