BMSN Investigational New Drug (IND) Application FDA Small Business Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069906.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069906.htm FDA Investigational New Drug (IND) Application www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm FDA What Is an Orphan Drug? www.fda.gov/ForConsumers/ConsumerUpdates/ucm107293.htm http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107293.htm FDA Accelerated Approval www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf FDA Fast Track www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf BMSN Will Be Approved For All The Above !!!