Following from a draft guidance published last June and consultations and revisions made subsequently, on April 1, 2010, a new guidance document will be in force with respect to the preparation of the Abbreviated New Drug Submissions (ANDSs) for veterinarian products. The stated purpose of this guidance document is to provide sponsors with an outline of the chemistry and manufacturing, clinical and safety requirements for ANDSs and changes to ANDSs and notifiable changes for veterinarian products. It should be noted that this guidance document also applies to veterinary and pharmaceutical products and certain veterinary drugs of biological origin which are regulated as drugs under the Food and Drugs Act. This document does not to supersede previous guidance documents noted therein.
For more information, please see the following link: