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2. FDA Expanded access to investigational drugs for treatment use-questions & answers http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm351261.pdf 2016
3. FDA Individual patient expanded access applications: Form FDA 3926 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM432717.pdf 2016
4. US Food and Drug Administration: Expanded access (compassionate use) http://www.fda.gov/ExpandedAccess 2016
5. FDA Charging for investigational drugs under an IND-questions and answers: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm351264.pdf 2016