“Endo”
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Rules and notices
Stay the Effective Date of FDA's Determination That Premarket Approval is not Required for a Recombinant Endotoxin Tests Intended for Endotoxin Testing of Human Drugs and Medical Devices; CLOSED: 10/5/2011
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
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