Scott Gottlieb

Author Archive

  • Oct 15, 2026
    For decades, academic hospitals developed and ran their own diagnostic tests without any regulatory review. A test built and used inside a single laboratory (laboratory developed...
  • Oct 13, 2026
    For decades, academic hospitals developed and ran their own diagnostic tests without any regulatory review. A test built and used inside a single laboratory (laboratory developed...
  • Jun 23, 2026
    The US Food and Drug Administration (FDA) is passing through an unsettled period.