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Pharmaceutical industry / Microbiology / Validity / Clinical research / Validation / Recombinant DNA / Meningococcal disease / Cleaning validation / Novartis / Biology / Quality / Biotechnology


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. / Novartis V&D Srl / Novartis Corporation / Novartis Vaccines and Diagnostics S.r.l. / /

Country

Italy / New Zealand / /

Currency

pence / /

Event

FDA Phase / /

Facility

Located In Building / Novartis Rosia Facility / New Hampshire Ave Building / Rosia Facility / Manufacturing Facility / /

IndustryTerm

drug product / residual product / biologic product / product contact equipment / degradation products / /

MedicalCondition

invasive meningococcal disease / invasive disease / /

MedicalTreatment

active immunization / /

Organization

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

Person

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

/

Position

Chair / OVRR/DBPAP / Branch Chief / General / Regulatory Officer / /

Product

eCTD / /

ProvinceOrState

Maryland / /

PublishedMedium

the Addendum Review / /

SocialTag