Transcription of October, 2012 LALUpdate
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October, 2012 LALUpdate
The New FDA Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers . October, 2012. LALU pdate volume 28, number 1. Letter From The Editor On June 29, 2012 FDA released the long awaited guidance document on pyrogen and endotoxin testing, almost exactly a year after the withdrawal of the former guidance documents (the 1987 Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For Human and Animal Parenteral Drugs, Biological Products and Medical Devices and the 1991 Interim Guidance for Human and Veterinary Drug Products and Biologicals: Kinetic LAL Techniques.)
LALUpdate volume 28, number 1 - October, 2012 I. INTRODUCTION This guidance provides recommendations for biological product, drug, and device firms on FDA’s current thinking concerning the testing recom-
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