FDA finalizes feedback processes for combo products

Regulatory NewsRegulatory News
| 03 December 2020 | By Kari Oakes 

Developers of combination products have new final guidance from the US Food and Drug Administration about requesting feedback from the agency during the full product development cycle.
In response to feedback received during the consultation period on the January 2020 draft guidance, FDA has adjusted the final guidance to give developers more information about the best use of combination product agreement meetings (CPAMs) as well as how agreements reached through CPAMs are structured and what they contain.
The guidance is issued as part of 21st Century Cures Act mandates that require FDA to provide sponsors of combination products with final guidance that addresses how structured pre-submission interactions occur, best practices in pre-submission interactions to ensure getting FDA’s best advice, and how CPAMS fit in with other meeting types and what information is needed for CPAM requests. (RELATED: Combination Products: New guidance details process for requesting feedback from FDA, Regulatory Focus 06 January 2020)
Combination products are defined as “a product comprised of any combination of a drug, device, and/or biological product.” The Office of Combination Products (OCP) is the point of contact if manufacturers are uncertain if their product qualifies as a combination product. The guidance walks manufacturers through appropriate points of contact depending on the submission status and type of combination product.
CPAMs are available to sponsors when the lead center for the combination product is clear. Sponsors should be clear and ask specific and appropriate question and provide a comprehensive rationale and sufficient supporting information that FDA can provide feedback “without the need for significant additional information requests.”
Even if the particular request requires expertise that lies outside the lead center, sponsors should still submit communications through the FDA POC who has been identified as the lead POC.
On its part, FDA will notify the sponsor of the FDA POC after a submission or request has been received. It is the lead center’s job then to engage relevant expertise throughout the agency as needed. By statutory right, “sponsors may also request that OCP participate in meetings or otherwise engage on regulatory matters concerning combination products,” according to the guidance. FDA should also consolidate feedback “from all Agency centers and groups involved in review of the submission/request.”
The final guidance discusses the variety of feedback mechanisms available to sponsors of combination products. Application-based mechanisms are “typically the most efficient and effective,” though CPAMs may also be used to address requirements for marketing authorization and postmarket modification of a combination product, among other items.
Information required for CPAM requests is detailed in the guidance, as is the submission procedure and FDA’s responses to the request. Except in limited circumstances defined by statute, agreements made through a CPAM will remain in effect.
Two appendices to the guidance give examples of issues that are appropriate for discussion via application-based mechanisms for the range of application types that might apply to combination products.


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