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# FDA Draft Guide on Endotoxin Limits
- URL: https://www.fdaweb.com/fda-draft-guide-on-endotoxin-limits/
- Published: 2020-07-29T12:00:00.000Z
- Updated: 2026-09-14T16:23:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147302

*Federal Register* notice: FDA has made available a draft guidance entitled “Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.” The document describes FDA’s current recommendations about endotoxin limits and discusses a risk-based approach of weighing the potential risks of not evaluating endotoxin levels in all components of a multidrug regimen against the potential benefits to patients with serious and life-threatening diseases. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-07-29/pdf/2020-16340.pdf?ref=fdaweb.com).