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Clinical research / Health / Clinical pharmacology / Therapeutics / United States Public Health Service / Center for Biologics Evaluation and Research / Structured Product Labeling / Biologic License Application / Biologic / Food and Drug Administration / Medicine / Pharmacology


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Company

Case Management / /

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Facility

CBER’s Document Control Center / /

IndustryTerm

telephone notification / manufacturing changes / manufacturing / licensed device applications / Internet Web / manufacturing information / /

Organization

Division of Manufacturing and Product Quality / FDA / FDA’s office of Regulatory Affairs / office of Blood Research / Division of Inspections and Surveillance / CBER’s office of Compliance and Biologics Quality / Center for Drug Evaluation and Research / CBER’s Document Control Center / Biologics Quality / CBER’s EDR / RESPONSIBILITIES A. Document Control Center / CBER’s office of Compliance / District Office / Center for Biologics Evaluation and Research / Review Committee / Product Office / /

Person

Linda Silvers Robert Yetter / Robert Yetter / /

Position

Copies supervisor / Governor / biologics license submissions Branch Chief / Director / Branch Chief / Director / all appropriate review staff / Division / review memo Regulatory Project Manager / /

URL

http /

SocialTag