In the July 21, 2016, Federal Register, FDA announced
the availability of a draft revised guidance for industry titled
"General Principles for Evaluating the Human Food
Safety of New Animal Drugs Used in Food-Producing
Animals." The guidance describes the types of information
that FDA's Center for Veterinary Medicine recommends sponsors
provide to address the human food safety of new animal drugs used
in food-producing animals. Specifically, the guidance provides an
overview of the process for the human food safety evaluation,
including: (i) determination of an acceptable daily intake;
(ii) calculation of safe concentrations; (iii) assignment of a
tolerance; (iv) calculation of a withdrawal period and a milk
discard time; and (v) evaluation of carcinogenic compounds.
Comments are due September 19,
2016.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
