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HHS - FDA GUIDANCE FOR INDUSTRY

GUIDELINE ON VALIDATION OF THE LIMULUS AMEBOCYTE LYSATE TEST AS ANEND-PRODUCT ENDOTOXIN TEST FOR HUMAN AND ANIMAL PARENTERAL DRUGS, BIOLOGICAL PRODUCTS, AND MEDICAL DEVICES

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Organization: HHS
Status: active
Page Count: 51

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FDA GUIDANCE FOR INDUSTRY
GUIDELINE ON VALIDATION OF THE LIMULUS AMEBOCYTE LYSATE TEST AS ANEND-PRODUCT ENDOTOXIN TEST FOR HUMAN AND ANIMAL PARENTERAL DRUGS, BIOLOGICAL PRODUCTS, AND MEDICAL DEVICES
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