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NICEATM-ICCVAM Home >> Test Method Evaluations>> Biologics and Vaccines >> Botulinum Toxin Testing

ICCVAM/NICEATM/ECVAM
Scientific Workshop on Alternative Methods to Refine, Reduce and Replace the Mouse LD50 Assay For Botulinum Toxin Testing

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Regulatory Information

Back to Botulinum Toxin Testing: Workshop Documents

Agenda and Additional Meeting Materials Workshop Presentations Regulatory Information


Testing Requirements, Regulations, and Practices

The following can be found on the Search Agency Guidelines/Regulations page:
  • U.S. Department of Agriculture (USDA):

    • Animal and Plant Health Inspection Service, USDA: Clostridium Botulinum Type C Bacterin-Toxoid.


  • U.S. Food and Drug Administration (FDA):

    • Definitions (4-1-05 Edition)

    • Potency (4-1-05 Edition)

  • European Pharmacopoeia 5.0:

    • European Pharmacopoeia on Botulinum Toxin A Testing

    • European Pharmacopoeia on Botulinum Antitoxin Testing










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