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Pharmaceutical sciences / FDA Special Protocol Assessment / Prescription Drug User Fee Act / New Drug Application / FDA Fast Track Development Program / Center for Biologics Evaluation and Research / Meeting / Investigational New Drug / Validation / Food and Drug Administration / Medicine / Health


SOPP[removed]: Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants Version #5 Effective Date: October 15, 2012 I. Purpose
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IndustryTerm

required communications / biological product / biological product applications / similar products / manufacturing / chemical / related products / non-user fee products / manufacturing information / manufacturing process / chemical name / /

Organization

Division of Manufacturing and Product Quality / PDUFA V / FDA / office of Blood Research / office of Compliance and Biologics Quality / Public Health Service / Food and Drug Administration / CBER Office / Center for Biologics Evaluation and Research / Applications Division / Deputy Office / /

Position

Deputy Director of Applications Branch / Director / Division / General development discussion / Director / /

ProgrammingLanguage

C / /

ProvinceOrState

Indiana / /

PublishedMedium

the CBER review / /

Technology

drug development / /

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