• FDA’s Center for Veterinary Medicine (CVM) has released a new guidance document (Guidance for Industry #3: General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals) describing the types of information that the Center expect to see when such drugs are used in food-producing animals.
  • Under Section 512(b)(1) of the Federal Food, Drug and Cosmetic Act, sponsors of new animal drugs are required to demonstrate the safety in edible tissues. The guidance addresses topics including:
    • Determining an acceptable daily intake (ADI);
    • Calculating safe concentrations;
    • Assignment of a tolerance;
    • Calculation of a withdrawal period and a milk discard time; and
    • Evaluation of carcinogenic compounds

This general guidance provides references to other CVM guidance documents that provide more detailed information on specific topics, such as conducting specific types of toxicity testing to evaluate residues of veterinary drugs (e.g., Guidance for Industry #116: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing).

  • Importantly, the guidance acknowledges that it is designed to address “traditional” new animal drugs that consist of small molecules and that it may not be applicable to evaluating the safety of “non-traditional” new animal drugs (e.g., biotechnology-derived new animal drugs, including some enzymes, fusion proteins, synthetic hormones, and antibodies). In these latter cases, CVM may be willing to consider alternative approaches to address toxicological concerns. In those cases, CVM recommends that the sponsor contact CVM early in the drug development process to develop studies to address toxicological concerns.