FDA finalized efforts to streamline the process used by physicians to request expanded access, often called compassionate use, to investigational drugs and biologics, as well as two guidance documents. “As a physician, I understand the importance of being able to access investigational treatments for a patient when there are no other options to treat their...
In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.
