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US Combo Product Designation Appeal Process Limited In Proposed Rule

Overhaul of reg on how combo products are designated to review centers eliminates the reconsideration appeal, but US FDA still allows appeals up the chain of command.

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 an ambiguous regulatory designation, should experience a less convoluted regulatory...

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