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FDA’s Combination Product Review Process: How It Looks Inside The Agency

This article was originally published in RPM Report

Executive Summary

Biopharma sponsors have precious little to complain about in the current new drug review process, but one area of concern has been uncertainty around combination product reviews. Once limited to diabetes and pulmonary drugs, device-related consults are much more common. FDA conducted its own internal review of the issues – and the findings suggest that the perceptions of sponsors are not far from those of FDA managers. The agency says it is making progress already on improving lines of communications. Here is the report.






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