Thursday 20 August 2020

Endotoxin Limits for Investigational Oncology Drugs and Biological Products

The U.S. FDA has issued an new guidance document titled “Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.” The document is currently in draft form (dated July 2020).

This guidance describes FDA’s recommendations to investigational new drug sponsors for setting endotoxin limits during the development of investigational drugs intended for use in combination with other approved drugs or for the codevelopment of two or more investigational drugs.

In keeping with the principles of facilitating drug development for serious and life-threatening diseases, this guidance outlines FDA’s current thinking on a risk-based approach to setting acceptance criteria for endotoxins during the clinical development of drugs intended to treat serious and life-threatening cancers.

For details see:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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