Combo Product Classification Guidance Doesn't Fix All Existing Problems, Experts Say
US FDA's tendency to designate products as drugs over devices may remain despite clarifications offered in final guidance.
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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.
The agency is still working to get an oncology center of excellence off the ground and has other large pending reorganizations to tackle before it may get to creating additional centers intended to break down device, drug and biologic silos.
Agency is still working to get oncology center of excellence off the ground and has other large pending reorganizations that could take precedence.