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 pathway for their products. Since the original rule was put into place, FDA new legislation and guidances have been issued. The updated rule is intended to make the regulations more consistent with how the agency currently reviews combo products
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