What's New at Charles River
   
 
 
   
   

FDA Withdraws 1987 Guideline for Endotoxin Testing

August 9, 2011 - As anticipated, effective 12 July 2011, the U.S. Food and Drug Administration (FDA) has withdrawn the "Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-product Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices" that was issued in 1987 and its subsequent 1991 amendment, "Interim Guidance for Human and Veterinary Drug Products and Biologicals, Kinetic LAL Techniques."

The FDA now refers drug manufacturers to the United States Pharmacopeia (USP) General Chapter <85> Bacterial Endotoxins Test (BET), which provides information on the performance and acceptance criteria for endotoxin testing.

To learn what this means for your endotoxin testing, click here.

For information on Charles River's full line of endotoxin detection products and services, click here.

   
Discover the full range of Charles River Products and Services
The Source

For more information, contact us at:

1.877.CRIVER.1 (1.877.274.8371)
askcharlesriver@crl.com

view all

News & Events

view all
Mar 02 - BioPharm International: Meeting Ch...
Feb 13 - Fourth-Quarter and Full-Year 2011 ...
Jun 02-Jun 05 - Vancouver, British Columbia - CALAS
Jun 05-Jun 08 - Saint Germain sur l’Arbresle, France - Charles River LAL Seminar Series
view all
Manager International Tax Wilmington, MA
Scientist I Wilmington, MA

Charles River Laboratories, Inc.