Primary-Mode-Of-Action Rule For Combo Products Is Similar To Earlier Draft
This article was originally published in The Gray Sheet
FDA's "primary-mode-of-action" 1final rule for combination products largely mirrors the language of last year's proposed version, although the agency adds clarification on various issues raised by stakeholders
You may also be interested in...
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.
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.
Companies should carefully consider their moves for ensuring proper evaluation of combination product applications, including looking at whether a formal request for designation really is needed, say industry and legal experts.