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.
You may also be interested in...
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.
Devices, or drug-delivery device, alternatives for pain control may provide at least a partial solution to the nation's opioid abuse epidemic, FDA Commissioner-nominee Scott Gottlieb said at his April 5 confirmation hearing before the Senate Health, Education, Labor, and Pensions Committee.