21 June 2017 - Johnson & Johnson and Medtronic are pushing back against the Australian TGA’s proposed priority review pathway for medical devices, citing faults in the proposal that they claim will keep them from using it.
The major medtech players said they had doubts whether the pathway, designed to hasten approval, would actually cut time to get medical devices to patients in the region. The companies also voiced concerns that the pathway could negatively impact new and breakthrough devices, according to the report.