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.
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Commissioner Gottlieb says upcoming guidance could help nudge products into preferred device realm if they are on cusp between drug or device jurisdictional designation.
Reorganization also may force change to commissioner succession plan.
What Is A Rare Pediatric Disease? US FDA's Orphan Products Office Hopes To Update Guidance On Definition
The Office of Pediatric Therapeutics is working with the Office of Orphan Products Development to make rare pediatric disease determinations, which can help sponsors obtain a priority review voucher.