Cutthroat trout, just one of many species AADAP works with to secure new approvals for medications used in aquaculture. (Photo: NPS)
Aquatic Animal Drug Approval Partnership
America’s fisheries are among the world’s richest in abundance and diversity. They provide scientific, aesthetic, recreational, commercial, subsistence, cultural, social, and economic benefits. FAC leads aquatic resource management for the Service and strives to invest its resources in the nation’s highest priority aquatic conservation and water-based recreational needs. Fish health is a critical component of healthy fisheries and core to the work of the Fish and Aquatic Conservation Program.
The Aquatic Animal Drug Approval Partnership (AADAP) program is part of the Fish and Aquatic Conservation fish health work. It is the only program in the United States singularly dedicated to obtaining U.S. Food and Drug Administration (FDA) approval of new medications needed for use in fish culture and fisheries management. Since the late 1990’s, AADAP has contributed to virtually every new fish medication approved by the FDA. Ultimately, the AADAP program allows fisheries professionals to more effectively and efficiently rear and manage a variety of fish species to meet production goals, stock healthy fish, and maintain a healthy environment.
Aquaculture Medications
Information to inform decisions regarding which medication to use, and how to use it. Safe, effective medications for treating fish diseases and managing fisheries—as well as informing the professionals who administer these medications—are growing needs.
Investigational New Animal Drug
Investigational New Animal Drugs (INADs) are available through the National INAD Program (NIP) and can be used as long as study parameters are met and work is being done to reach full drug approval.
Highlights
AADAP's New INAD U webpage
Do you wish there was a webpage you could visit to answer any INAD questions that you may have? Can't remember how to add another fish species to your investigator account or even what is needed to get started with the INAD Program? Well, now you're in luck as AADAP has compiled the most common INAD questions that we've received and posted the answers to our new INAD U webpage!
Please visit INAD U for information that includes: how to add enrollment to your investigator account; how to change out an investigator or monitor; adding receipt of drug to the inventory page; and many more fascinating INAD topics. We hope to keep adding to this webpage with more how-to videos and additional INAD reference guides. Be sure to mark this webpage as a favorite as it is sure to be your go-to page whenever you have questions about the INAD Program.
Expert Presenters Invited for Aquaculture America 2021
Calling all Aquaculture America 2021 attendees! Are you interested in speaking in a special session at Aquaculture America 2021, to be held in San Antonio, Texas from August 11-14th, 2021. Please follow the link below to learn more about the National Aquaculture Association (NAA) special sessions that AADAP is co-hosting with the Aquatic Drug Approval Coalition (ADAC) and the Association of Fish and Wildlife Agencies-Drug Approval Working Group (AFWA-DAWG).
Summary of Findings of the National Aquaculture Association’s Survey of Broodstock in Aquaculture and Drug Indexing
The National Aquaculture Association (NAA) and the Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM) began discussions on the opportunity to allow indexing of drugs for non-food life stages of food species where there was a reasonable certainty that the treated animal would not be used as human food, nor fed to another food-producing animal. Beyond early life stages, broodstock were identified as a group that currently meet, or could meet these criteria if indexing was available. The NAA and FDA-CVM developed a national survey that was intended to identify aquaculture species, potential compounds that might be used, number of animals involved, practices to delineate broodstock from other animals on the farm, and whether broodstock ever entered the human food chain. The survey also included questions about extension and outreach, and other permits, certifications, or regulations that might reinforce an index label.
NOW AVAILABLE: Newly-updated version of AADAP's Quick Desk Reference Guide!
AADAP's Quick Desk Reference Guide to Approved Drugs for Use in Aquaculture has been updated with the newest indications! This guide is an easy to use resource that outlines which aquaculture drugs are approved by FDA and what they can be used for. Additionally, it contains examples for calculating the amount of each drug to use for a particular situation. You can download the latest version of AADAP's Quick Desk Reference Guide to Approved Drugs for Use in Aquaculture (updated July 2020) from the Resources webpage. Hard copies of the updated Quick Desk Reference Guide will be available once all AADAP staff have returned to the the office.
How to Enroll in the Investigational New Animal Drug (INAD) Program
Do you want to enroll in the AADAP National INAD Program but don’t know where to start? Check out this brief video tutorial which outlines the process of enrollment for study monitors and study investigators. This video tutorial is the first in a series of tutorials that AADAP is creating to make the INAD enrollment/participation process more intuitive and efficient. We are also creating a brief video to outline AADAP’s role in the drug approval process. Stay tuned to the AADAP website to access more videos in the future!
