Per the ADUFA V goals letter, beginning in FY 2024, FDA will report quarterly in FDA‐TRACK the number of H submissions submitted to each review division in the Office of New Animal Drug Evaluation. H submissions have a 100-day review clock and are submitted under Investigation New Animal Drug files in support of a meeting request, in support of a protocol, or to reach agreement on the raw data to submit in a Target Animal Safety data submission.
Note: Current Fiscal Year represents performance year-to-date. (10/1/2023 - 12/31/2023)
|Division of Animal Biotechnology and Cellular Therapies
|Division of Business Information Science and Management
|Division of Companion Animal Drugs
|Division of Food Animal Drugs
|Division of Human Food Safety
|Division of Manufacturing Technologies
|Division of Scientific Support
Note: The data provided on this website are produced on an ongoing basis for performance management purposes and are subject to change due to updates of preliminary estimates, corrections, or other reasons.