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cowboydancer

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cowboydancer

Re: stervc post# 35586

Sunday, 02/24/2013 11:02:27 AM

Sunday, February 24, 2013 11:02:27 AM

Post# of 158400
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

FDA Investigational New Drug (IND) Application
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm

FDA What Is an Orphan Drug?

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107293.htm

FDA Accelerated Approval

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf

FDA Fast Track

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf


BMSN Will Be Approved For All The Above !!!


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