White Paper

The First Step To Navigating Your Combination Product's Regulatory Pathway: PMOA

Source: Phillips-Medisize

To avoid unnecessary delays and gain speed to market through ‘right the first time’ regulatory submissions for a combination product, sponsor companies must understand the various pathways for which a combination product can travel. Each of these pathways is based on correctly determining a key piece of information – the product’s primary mode of action (PMOA).

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