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  • New Guideline on Statistical Principles for Veterinary Clinical Trials Released by EMA

    A new guideline released by the European Medicines Agency (EMA) on 23 January updates the agency's thinking on the statistical principles to be considered while investigating veterinary pharmaceutical products. The guidance, Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals) , is similar to its human medicines counterpart ( Guidance on Statistical Principles or Clinical Trials), and provides insight on the desi...
  • Report, Guideline on Target Animal Batch Safety Test for Vaccines Released by EMA

    The European Medicines Agency (EMA) released a report and a guideline on 23 January about target animal batch safety tests (TABST) for veterinary vaccines. EMA has been trying to implement a waiver system for TABST requirements for marketing authorization holders (MAHs), but has received significant pushback from companies claiming that the waivers aren't worth their time. The report highlights their concerns, while the guideline revises the data requirements necessar...