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.
You may also be interested in...
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.
Cures Bill Authorizes Inter-Center Institutes, But Will US FDA Create Them?
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.
Cures Bill Authorizes 'Intercenter Institutes,' But Will US FDA Create Them?
Agency is still working to get oncology center of excellence off the ground and has other large pending reorganizations that could take precedence.