FDA floats expedited approval for unmet needs

FDA floats expedited approval for unmet needs-massdevice: The FDA said the "Expedited Access Pre-market Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions" would feature "earlier and more interactive engagement with FDA staff – including the involvement of senior management and a collaboratively developed plan for collecting the scientific and clinical data to support approval."