Posted 05 February 2016
By Suzette Roan, JD, John Towns, PhD
This article provides an overview of combination products and practical suggestions and strategies for regulatory affairs professionals when developing global submission strategies and contributing to development and design control activities.
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Categories: Combination products, Research and development, Submission and registration, Features, US, Europe, FDA, EMA, EC, ICH, IMDRF
Tags: Combination products, Design validation, Risk management, IMDRF