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Medical Devices 2021 - FDA's Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices



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The FDA posted on their web site on Tuesday, July 12, 2011 a notice that they had withdrawn the 1987 Guideline on Validation of the Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human Parenteral Drugs, Biological Products and Medical Devices.
The FDA referenced, however, three documents that they believe have more than offset the previous FDA Guidance that was withdrawn. They advise that these documents be referenced for the fundamental principles of the gel clot, photometric and kinetic test methods.
Examine the Background of the 1987 Guidance for Industry document,
Review current testing requirements,
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP

Last modified: 2021-01-16 00:18:28