DIN Fee Increase Effective April 1st, 2019
By: Sarah Calder, Regulatory Affairs Specialist, email
Notice: Fees associated with drug submission applications for Human and Disinfectant Drugs increase April 1st, 2019.
Fees have been updated and forms are available online.
The following submission types and associated fees are in effect April 1st:
|Category IV Monograph/Labeling Standard||$1,797.00|
Also coming into effect on this date, is the requirement for disinfectant drug submissions under the Administrative DIN pathway to be simply copy products. Master copies based of the large master product labels will now be submitted under the Labeling Only pathway.
If you have any questions regarding these changes, contact Dell Tech today.