Latest From Kate Rawson
Revised draft guidance makes clear that sponsors may charge all patients a flat administrative fee to cover ‘startup’ costs, regardless of when they join.
Commissioner Robert Califf’s comments offer further context for FDA’s unprecedented decision to reconvene an advisory committee for a second review of Amylyx’ AMX0035 for ALS.
Janet Woodcock’s imminent departure from FDA has been predicted often during her tenure. Her latest project may keep her there longer than even she thought possible.
Janet Woodcock’s imminent departure from the agency has been predicted often during her tenure. Her latest project may keep her there longer than even she thought possible.
Accelerated Approvals Convert Much Faster If Confirmatory Trial Already Underway, FDA Cancer Data Shows
Oncology Center of Excellence’s ‘Project Confirm’ finds that if a confirmatory trial is ongoing at the time of accelerated approval, conversion to regular approval takes an average of three years versus 4.9 years if the trial starts after AA.
Peter Marks predicts that staffing challenges within CBER can be alleviated by offering employees the flexibility to work remotely – permanently. With important posts in the vaccines office still to be hired, it could be an important incentive.