Fish and Aquatic Conservation

Information iconCutthroat 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.

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photo of rainbow trout eggs
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.

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photo of Milt being collected from a wild Yellowstone cutthroat trout male to be used for genetic infusion
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.

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Research

Researchers use sound science to evaluate the safety and effectiveness of experimental fish medications. Results support FDA approval of the medications.

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photo of the Bozeman Fish Technology Center and AADAP
Resources

Along with a knowledgeable staff ready to be of assistance, the AADAP program produces and makes available a variety of informational and educational materials, from reference guides to peer-reviewed publications.

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Highlights

2020 Aquaculture Drug Approval Coordination Workshop

Due to the COVID-19 pandemic, this year's Aquaculture Drug Approval Coordination Workshop has been postponed until the week of July 26th, 2021.  However, due to the importance of the topics planned for the 2020 Workshop, we are in the midst of developing a virtual platform to hold a portion of the meetings and discussions this July.  Below is a tentative line-up of virtual presentations.  Please note that each session will have time for Q&A: 

Tuesday, July 28th, 2020 at 9:00 AM-10:00 AM (Mountain Time): FDA Center for Veterinary Medicine (CVM) Updates Session
Tuesday, July 28th, 2020 at 10:00 AM-11:00 AM (Mountain Time): Indexing Session
Thursday, July 30th, 2020 at 9:00 AM-10:30 AM (Mountain Time): Effluents Session
As the agenda develops, we'll make an announcement via the AADAP Update and AADAP website. Thank you for your patience and understanding during this difficult time!


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!

Link to the video


INAD Program Updates - GnRH IIa Announcement

AADAP recently received FDA authorization to open the GnRH IIa INAD #13-345 for participation. GnRH IIa is a spawning hormone to aid in the spawning of female ictalurid catfish. DelTaq Fish Health LLC is the manufacturer for this INAD. Please see the GnRH lla web fact page for more information. The INAD is ready for enrollment through the online database. Please contact bonnie_johnson@fws.gov for more information.


AADAP’s Needs for Efficacy Studies

AADAP is on the lookout for facilities with the following conditions/species combinations in which to conduct efficacy studies:

If you know of any facilities with these conditions, please have them contact AADAP directly.  Thank you!


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