FDA Offers Sponsors Advice on Getting Feedback for Combination Products
The FDA has issued a final guidance explaining how sponsors of combination products can get the agency’s feedback on their applications using combination product agreement meetings (CPAMs).
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 product and its constituent parts, the agency said. Among other details, sponsors should also include summaries of any previous interactions with the FDA on the product and the proposed regulatory pathway, if not already established.