Combination Product Designations At US FDA Need Faster Appeals, Petition Says
No sponsor is named in the citizen petition, but it was filed on behalf of an applicant that has had an appeal of a designation decision 'under consideration' for 18 months and counting.
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The final guidance adds some requested clarifications, but does not appear to address the US agency's tendency to designate products as drugs over devices, industry attorneys argue.
US FDA's tendency to designate products as drugs over devices may remain despite clarifications offered in final guidance.