User fees increase
User fees for fiscal 2003 increase 70% over prior year, according to rates announced in the Federal Register Aug. 2. Prescription Drug User Fee Act fees will be $533,400 for an application requiring clinical data; $266,700 for an application not requiring clinical data or a supplement requiring clinical data; $209,900 for establishment fees; and $32,400 for product fees. FY 2002 adjusted fees were $313,320 for applications requiring clinical data and $156,660 for applications not requiring clinical data or supplements requiring clinical data....
You may also be interested in...
During oral argument in the Arthrex case, several justices seemed to agree with the Federal Circuit that PTAB judges should have been appointed by the president. They could opt to get around the problem by enabling the PTO director to review all panel decisions.
House Bill 2325, on a fast track in West Virginia, would bar the state’s Board of Barbers and Cosmetologists from regulating unlicensed individuals’ use or application of “generally available” cosmetic products for paying clients. PGA’s government affairs team provides detail.
This time we touch on Pfizer’s R&D plans, real-world evidence for coronavirus vaccines, a new approval in lung cancer, challenges for Galapagos, and Takeda's pipeline story.