New Guidance for Combination Products

As interest in developing innovative combination products continues to grow, industry has turned to FDA for additional guidance on how to navigate the differing policies and review procedures of the FDA Centers that regulate the product components and how to receive timely responses on issues such as requests for designation, pre-submission guidance, and primary jurisdiction.

This program will also focus on several recent new guidances and rules intended to simplify the process as well as on new and ongoing initiatives at FDA and reactions from industry.