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US Combo Product Designation Appeal Process Refined In Proposed Rule

In an overhaul of a regulation that sets out how US FDA designates combo products to product centers, the agency is proposing to update its policies so they align with current practices and mandates. FDA is also specifically proposing to streamline a designation appeal process that it says has been a burden for all parties.

US FDA is proposing to remove one appeal option for sponsors after a lead center has been designated for the review of their product. In a proposal to update a 2005 regulation that describes which product office gets jurisdiction over a combination product based on its primary mode of action (PMOA), the agency says the appeal process in its current form has been "inefficient" and "unhelpful."

On May 15, the agency published the proposed rule update, stating that makers of combination products, or products with...

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