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To Regulate Recombinant and any Other Previously Unlicensed Endotoxin Detection Tests for Validation, In-Process and Finished Product Endotoxin Testing of Drugs, Biological Products and Medical Devices in Accordance With the Same Requirements That Have Been Applied to Limulus Amebocyte Lysate (LAL) Endotoxin Detection Tests for the Past 30 years-CLOSED

🏛 Food and Drug Administration (FDA)FDA-2003-P-0333
Biomedical Research
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📄 Primary document
OtherDec 10, 2003
Letter from FDA CBER to Hyman, Phelps & McNamara
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