FDA CVM Guidance Documents Under Development for 2014

On January 24, 2014, in FDA, by Harrison Kircher

The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) has issued its guidance list for industry that it expects to publish as drafts or finals by the end of December 2014.

Some of the topics include:

  • Marketed Unapproved New Animal Drugs
  • FDA Approval of Animal Drugs for Minor Uses and for Minor Species
  • Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods
  • Human Food Safety for Protein/Peptide Drugs
  • Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing
  • Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose
  • Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds
  • Use of Nanomaterials in Food for Animals
  • Ensuring Safety of Animal Food Maintained and Fed On-Farm
  • Preventive Controls for Food for Animal Foods Under FSMA

The January 22, 2014 FDA CVM Guidance for Industry update, titled “Guidances Under Development for 2014,” is available here.

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