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Pharmaceutical sciences / Pharmacology / Clinical pharmacology / Therapeutics / United States Public Health Service / Premarket approval / Allotransplantation / Medicine / Food and Drug Administration / Health


January 30, 2014 The Honorable Margaret A. Hamburg, M.D. Commissioner U.S. Food & Drug Administration White Oak Office BuildingNew Hampshire Avenue
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Document Date: 2014-03-12 17:47:18

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Company

Shire PLC / Organogenesis / /

Facility

Drug Administration White Oak Office Building / /

IndustryTerm

wound care products / unproven products / wound management devices / cell-based regenerative medicine products / products / chronic wound healing products / /

MedicalCondition

chronic wound healing therapies / chronic wounds / innovative chronic wound healing products / chronic wound care products / chronic wound healing products / /

MedicalTreatment

innovative therapies / /

Organization

FDA / Massachusetts Biotechnology Council / Food and Drug Administration / Medicare / /

Position

Wound Care Products Dear Commissioner / Robert K. Coughlin President & CEO / Commissioner U.S. Food / /

ProvinceOrState

Maryland / /

Technology

Biotechnology / regenerative medicine / /

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