Recently, the U.S. Food and Drug Administration (FDA) issued draft guidance on requesting feedback from the agency related to scientific and regulatory questions during the development of a combination product. The guidance fulfills an obligation under the 21st Century Cures Act to publish guidance on best practices when seeking feedback on combination products and to explain how combination product agreement meetings (CPAMs) work. CPAMs are meant to provide combination product sponsors with clarity and certainty about a product when the lead review center is clear.
Guidance
As FDA describes, a combination product is a product comprised of any combination of a drug, a device, and/or a biological product. The drugs, devices, and biological products included in combination products are referred to as “constituent parts” of the combination product. If an entity is uncertain as to whether their product is a combination product or a constituent part of a combination product, or which center has primary jurisdiction for the product, FDA says they can contact the Office of Combination Products (OCP). If they wish to obtain a binding determination from FDA regarding classification and/or center assignment, they may submit a request for designation (RFD) to OCP, or to obtain informal feedback, they may submit a pre-RFD to OCP.
Regarding the best practices for interactions between FDA and sponsors for combination products, the agency suggests sponsors should first post clear and appropriate questions. FDA explains the specific feedback being requested should be clear in the questions being posed. Also, the questions should be appropriate to the stage of combination product development. For example, it would not be productive to ask questions related to full-scale manufacturing process controls if, for instance, the composition/design of the combination product is still being developed.
Second, FDA says sponsors should provide comprehensive rationale and supporting information. The submission/request should include sufficient information to allow FDA to consider the issue(s) and provide feedback without the need for significant additional information requests. When requesting FDA feedback on a particular issue, sponsors should provide sufficient information, as applicable, about how the issue relates to the constituent part(s) as well as the overall combination product.
Third, sponsors should communicate through the identified FDA POC. FDA says even in situations where the focus of the request is an issue for which expertise primarily resides outside the lead Center, communications should be directed to the identified POC within the lead Center who will engage appropriate expertise.