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missionaryman

04/20/15 4:21 PM

#22373 RE: Tcsxyz #22369

Just looks to me like an industry wide info sheet - "Generic Drug User Fees" (GDUFA)or something like that
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rookie116

04/20/15 4:33 PM

#22378 RE: Tcsxyz #22369

Per the attached FDA PPT, an FEI Number (on spreadsheet) is issued for, "Business or other entity (handles products or performs activities subject to FDA jurisdiction)"

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM358194.pdf