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  • FDA Guidance on Veterinary Antibiotic Use Prompts Compliance, Criticism

    Shortly after the US Food and Drug Administration (FDA) released new rules to curtail the "injudicious" use of antibiotics in food-producing animals , three pharmaceutical manufacturers said they were agreeing to change the labeling on their veterinary antibiotics to exclude indications for food-producing animals, reports Bloomberg . FDA Deputy Commissioner for Foods Michael Taylor said he has assurances from Pfizer Inc., Eli Lilly & Co. and Merck & Co.-three o...
  • New FDA Guidance on Evaluation of Veterinary Stability Data

    A new draft guidance for industry out of the US Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) aims to implement the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products' (VICH) GL51 quality measure. The draft guidance, Statistical Evaluation Of Stability Data (VICH GL51) , was released 4 April and deals with Step 4 of VICH's 9-step procedure . "This draft guidance is intended...
  • FDA Releases New Veterinary CMC Guidance

    The US Food and Drug Administration (FDA) is releasing new guidance for industry for chemistry, manufacturing and controls (CMC) information relating to fermentation-derived products, including intermediates, drug substances and related drug products for veterinary medicinal use. The guidance "provides recommendations on what documentation to submit to support the [CMC] information" for veterinary products to the Center for Veterinary Medicine (CVM). "This information i...
  • 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...
  • Draft Guideline Released by EMA on Pharmacological ADIs for Veterinary Medicinal Products

    The European Medicines Agency (EMA)  released a draft guideline  on 23 January on pharmacological acceptable daily intake (ADI), titled Guideline on the approach to establish a pharmacological ADI . The guideline advises when to establish a pharmacological ADI, how to conduct studies and what endpoints must be addressed. EU legislation requires that any food produced from animals that are treated with veterinary medicinal products be free from medicinal residu...