Primary source: Drug Alerts and Statements
The new testing method for endotoxins is now approved as an alternative to the traditional Limulus Amebocyte Lysate (LAL) test, allowing for the use of recombinant endotoxins testing without horseshoe crab-derived materials.
This change supports animal welfare by reducing reliance on animal-derived materials, aligns with FDA's commitment to modernizing pharmaceutical testing, and enhances global regulatory coordination, thereby facilitating more timely patient access to medicines.
Regulatory compliance processes may need updates to incorporate the new recombinant endotoxins testing method and guidelines established under the ICMRA framework.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Regulatory compliance processes may need updates to incorporate the new recombinant endotoxins testing method and guidelines established under the ICMRA framework.
FDA, in partnership with the International Coalition of Medicines Regulatory Authorities (ICMRA), has finalized an assessment of a new recombinant endotoxins testing approach that aims to reduce the reliance on horseshoe crab blood for biological products. This assessment is part of the ICMRA Collaborative Assessment Pilot, which enables simultaneous review of manufacturing changes by multiple international regulators.
What changed: The new testing method for endotoxins is now approved as an alternative to the traditional Limulus Amebocyte Lysate (LAL) test, allowing for the use of recombinant endotoxins testing without horseshoe crab-derived materials.
Why it matters: This change supports animal welfare by reducing reliance on animal-derived materials, aligns with FDA's commitment to modernizing pharmaceutical testing, and enhances global regulatory coordination, thereby facilitating more timely patient access to medicines.
Practical implication: Regulatory compliance processes may need updates to incorporate the new recombinant endotoxins testing method and guidelines established under the ICMRA framework.
Published from the regulator source ingestion pipeline after PV impact triage.
AZRL LTD must proceed with the recall of FastPen 40mg from all locations and suspend marketing activities until compliance is verified.
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Laboratories must immediately quarantine and return the affected product, and communicate with patients to manage their follow-up testing appropriately.
