USA – FDA details feedback request process for combo products

Developers of combination products have new final guidance from the US Food and Drug Administration about requesting feedback from the agency during the full product development cycle.

In response to feedback received during the consultation period on the January 2020 draft guidance, FDA has adjusted the final guidance to give developers more information about the best use of combination product agreement meetings (CPAMs) as well as how agreements reached through CPAMs are structured and what they contain.
The guidance is issued as part of 21st Century Cures Act mandates that require FDA to provide sponsors of combination products with final guidance that addresses how structured pre-submission interactions occur, best practices in pre-submission interactions to ensure getting FDA’s best advice, and how CPAMS fit in with other meeting types and what information is needed for CPAM requests. (RELATED: Combination Products: New guidance details process for requesting feedback from FDA, Regulatory Focus 06 January 2020)…