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Pharmacology / Pharmaceutical industry / Clinical research / Validity / Alemtuzumab / Biologic / Center for Biologics Evaluation and Research / Validation / Bayer HealthCare Pharmaceuticals / Food and Drug Administration / Pharmaceutical sciences / Biotechnology


I DEPARTMENT OF HEALTH &aHUMAN SERWCES Food and Drug Administration
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City

Cambridge / Rockville / /

Company

ILEX Partners LP / Berlex Laboratories / FACP / Masiello / /

Event

FDA Phase / /

Facility

MD Pike / Rockville Pike / /

IndustryTerm

manufacturing deviations / drug product / final formulated product / manufacturing facilities / manufacturing / sale-of biological products / licensed biological products / manufacturing supplement / /

MedicalCondition

B-cell chronic iymphocytic leukemia / disease / Progressive B-Cell Chronic Lymphocytic Leukemia / infectious diseases / /

MedicalTreatment

vaccinations / /

Organization

office of Compliance and Biologics Quality / Food and Drug Administration / Department of Health and Human Services U.S. License / FACP Director office of Therapeutics Research / DEPARTMENT OF HEALTH / Foodand Drug Administration / Center for Biologics Evaluation and Research / office of Compliance and Biologics Quality Center for Biologics Evaluation and Research / /

Person

Jay P. Siegel / Michael A. Recupero Millennium / Cell Chronic Lymphocytic Leukemia / /

Position

Director / /

Product

Campath / CAMPATH-1H / /

ProvinceOrState

Maryland / Massachusetts / /

Technology

Pharmacokinetics / antibodies / PDF / /

SocialTag