FDA Instructs Combination Product Sponsors on Obtaining Agency Feedback

Combination product agreement meetings — known within the FDA as CPAMs — are an essential tool sponsors can use to gather agency input on their applications, the agency said in a final guidance released late last week.

If a sponsor asks in writing for a CPAM, the FDA must meet with the sponsor within 75 calendar days of receiving the request, the agency said, adding that the FDA will document any agreements it makes with the sponsor and add them to the administrative record.

When asking for a meeting, sponsors should include product information, such as a description of the combination product and constituent parts and proposed indications, the agency said. They should also include summaries of any previous interactions with the FDA on the product and the proposed regulatory pathway, if not already established.