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FDA Guidance for Industry: Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products
Origin/Publisher:
Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002
Document Type:
Draft Guidance
Content:
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
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