"Emergency Use of an Investigational Drug or Biologic,"
"Emergency Use of Unapproved Medical Devices,"
"Waiver of IRB Requirements" and "Treatment use of Investigational Drugs and Biologics."

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm