Why is Health Canadas Veterinary Drugs Directorate (VDD) proposing this interim policy on Outstanding Responses to Additional Data Letters (ADLs)?
The Veterinary Drugs Directorate currently has a significant number of submissions for which ADLs were sent to request additional or revised information in order to continue with the review of the sponsors submissions. There are over 200 outstanding ADL requests that have been in the system for more than two years. VDD has determined that this situation has a serious impact on the validity of the data submitted especially if a response is received several years after the ADL is sent. This proposed interim policy outlines the circumstances under which VDD will handle submissions that have outstanding responses to ADLs.
