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Biology / Application programming interface / Technical communication / Alpha 1-antitrypsin / Assay / Serpin / Chemistry / Medicine / Laboratory techniques


Clinical Review Memorandum
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File Size: 50,60 KB

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City

Beit Kama / /

Company

Kamada Ltd. / Intravenous (Human) Trade / Background Summary Kamada Ltd. / /

Country

United States / Israel / /

Event

FDA Phase / /

IndustryTerm

non-sterile buffered solution / validation protocols / ready-to-use solution / manufacturing process / /

MedicalCondition

AAT Deficiency / chronic lung inflammation / sterility / emphysema / congenital deficiency / API Deficiency / co-dominant / hereditary disorder / chronic augmentation / pulmonary tissue / severe emphysema / chronic bronchitis / /

MedicalTreatment

intravenous infusion / /

NaturalFeature

Negev / /

Organization

Food and Drug Administration Center for Biologics Evaluation and Research Date / Department of Health and Human Services / /

Person

Dorothy Scott / Cherie Ward-Peralta / Douglas J. Frazier / Negev / /

Position

MP / Biologist / Chief / /

Product

Sodium Chloride / DS / API001 / Alpha-1 / Kamada-API / /

ProvinceOrState

Nebraska / /

Region

Mediterranean / /

Technology

Alpha / API / approved validation protocols / /

SocialTag