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 FDA | CDER | Small Business and Industry Assistance
INDUSTRY NEWS
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FDA and Global Regulatory Partners Advance Modern Endotoxins Testing, Reducing Reliance on Horseshoe Crab Blood
Today, FDA announced the approval of a Post-Approval Change Management Protocol that allows a manufacturer to transition from a traditional lysate-based bacterial endotoxins test that uses horseshoe crab-derived materials to a modern recombinant endotoxins testing method. The recombinant method does not require horseshoe crab-derived materials and supports the 3Rs principles of replacement, reduction and refinement of animal use.
The approved protocol can be used for multiple biological products. This gives manufacturers a more streamlined approach for making the testing change.
FDA reviewed the protocol with the European Medicines Agency, Australia’s Therapeutic Goods Administration, Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency, and Swissmedic through an International Coalition of Medicines Regulatory Authorities collaborative review pilot. Under the pilot, regulators reviewed the same proposed manufacturing change at the same time, coordinated their questions to applicants, and made decisions within a standard 120- day review timeline.
This approval supports FDA's efforts to reduce reliance on animal-derived materials, modernize product testing and work with international regulators while continuing to ensure product quality. The collaborative approach can also reduce duplicative regulatory work, improve predictability, and support more efficient review of certain manufacturing changes. Work is underway to build on the pilot and develop a more sustainable, globally coordinated regulatory approach.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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