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GUIDANCE DOCUMENT

Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry Draft Guidance for Industry July 2020

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2020-D-1294
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

New approvals in oncology often build on prior success by adding new drugs to current regimens or by combining products in a novel treatment regimen, creating new multidrug regimens that may have greater efficacy.

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. The scope of this guidance is limited to anticancer drugs, including combination products under 21 CFR Part 3, as described further in this guidance and administered parenterally (except for intraocular administration) to treat serious and life-threatening cancers based on histology or stage of disease. This guidance does not apply to the development of drugs for adjuvant or neoadjuvant treatment or for cancer subtypes that can be cured or where prolonged survival can be achieved with available therapy.

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All written comments should be identified with this document's docket number: FDA-2020-D-1294.

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