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Pharmaceutics / Biotechnology / Clinical research / Molecular genetics / Validation / Verification and validation / Recombinant DNA / Novartis / Vaccine / Pharmaceutical industry / Validity / Biology


DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Center for Biologics Evaluation and Research[removed]New Hampshire Ave
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Company

Novartis Vaccines and Diagnostics Inc. / Primary Review / Novartis Vaccines and Diagnostics S.r.l. / OCBQ / /

Facility

Rosia Facility / Facility Reference Processing Filters Question / Novartis Rosia DS/DP Facility / Facility Reference / New Hampshire Ave Building / Meningococcal Group B Vaccine Manufacturing Facility / /

IndustryTerm

multi-product manufacturing facility / manufacturing / product contact equipment / drug product / fermentation equipment / manufacturing process / /

MedicalCondition

invasive meningococcal disease / /

MedicalTreatment

active immunization / /

Organization

Food and Drug Administration Center for Biologics Evaluation and Research / DEPARTMENT OF HEALTH AND HUMAN SERVICES / /

Person

Donald Ertel / Jay Eltermann / Edward Wolfgang / Carolyn Renshaw / Silver Spring / Margaret Bash / /

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Position

Chair / Branch Chief / Director / OCBQ / Division / Regulatory Officer / Director / OCBQ Division / /

ProvinceOrState

Maryland / /

SocialTag