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Risk-based Approach to Combination Products Advocated to Improve Communications with Regulators and Streamline Filing

Mar 31st, 2011

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A risk-based approach could clarify and simplify the regulatory pathway for combination products, Lilly CMC Regulatory Affairs Principle Consultant LeAnn Chambers maintained at a DIA CMC Workshop in February.

At the workshop, Chambers presented a model for how this risk-based approach could be applied to help manufacturers of these complex products chart a course through the maze of regulatory rules and standards that relate to them and avoid unnecessary constraints and work.

“When communicating about your combination product with the authorities,” she suggested, “I think there is a way that a risk-based approach can be used to understand the combination better and…set the stage for defining what data needs to be collected.”

[More on Chambers’ insights and proposal is provided for subscribers beginning on page 2. See also the IPQ “In the News” companion stories on combination product regulatory developments in the US and in Europe and Japan. Nonsubscribers may purchase the full stories for $195 each by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

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