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Coagulation system / Acute phase proteins / Gross pathology / Fibrinolysis / Fibrin glue / Coagulation / Thrombin / Aprotinin / Seroma / Blood / Anatomy / Biology


Summary Basis for Regulatory Action Date From Subject BLA Supplement# Applicant
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Company

Case Management / AEs / Pharmacology/ Toxicology Review / Baxter Healthcare Corporation / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

thrombin products / study site / chemical composition / investigational product / aprotinin solution / concentrated solutions / chloride solution / manufacturing process / /

MedicalCondition

shear irritation / disease / infectious / burns / infectious agents / /

MedicalTreatment

cardiovascular surgery / skin grafts / drainage / rhytidectomy surgery / Facelift surgery / rhytidectomy / face rhytidectomy / surgery / /

Organization

Approval Basil Golding____________________________ Offices Signatory Authority / office of Compliance and Biologics Quality / FDA / John Eltermann______________________________ Offices Signatory Authority / Division of Case Management / /

Person

Laura Wood / Mitchell Frost / Marc A. Alston / John Eltermann / Laura Wood Epidemiology / Jie He / Boris Zaslavsky / /

Position

Nguyen Regulatory Project Manager / Chair / Committee / Chair Committee / /

Product

sodium chloride / Calcium Chloride / thrombin / Fibrin Sealant / /

Technology

alpha / Pharmacokinetics / polymerization / /

SocialTag