Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry Draft Guidance for Industry July 2020
Not for implementation. Contains non-binding recommendations.
- Docket Number:
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-1294.