Practical Guidance for Regulatory Professionals on Combination Products

Posted 05 February 2016 By Suzette Roan, JD, John Towns, PhD

placeholder+image 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

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