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More Talk, Less Work: US FDA Outlines Expectations For Combo Products Discussions

A new FDA draft guidance says manufacturers of combination products should first review existing combination product guidances and submit questions before asking for a combination product agreement meeting with regulators to get clarification. The guidance outlines what is expected of both sides in such meetings.

FDA entrance sign 2016

Before coming to the US Food and Drug Administration to set up a meeting about combination products review, sponsors should first read up on guidances the agency has already put out and submit questions in digital form, such as through the FDA's Center for Devices and Radiological Health's (CDHR) pre-submission process. Then, manufacturers can set up a face-to-face meeting with regulators to clarify issues.

On 23 December, the FDA published its draft guidance titled, "Requesting FDA Feedback on Combination Products," that summarizes the agency's expectations for combination product agreement meetings (CPAM). The meetings...

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