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Combination Product Sponsors Should Consider Traditional Pathways Before Asking For Meeting, US FDA Says

In a final guidance from the US agency, regulators say most combination product questions are best resolved through traditional pathways and noted that initiating a so-called combination product agreement meeting may be unproductive.

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Combination product sponsors are strongly encouraged by the US Food and Drug Administration to use traditional application-based mechanisms to address questions about their product before requesting a combination product agreement meeting (CPAM), according to a final guidance. Asking for a CPAM, especially to answer unresolved scientific questions, may be unproductive.

The agency published its final guidance “Requesting FDA Feedback on Combination Products” on 3 December. It lays out its...

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