Aquatic Animal Drug Approval Partnership Program

The Aquatic Animal Drug Approval Partnership is a fish medicine research and development program.   

This small team of research professionals contribute thousands of hours in the lab and field to make sure that fisheries managers across the country have access to a well-stocked fish medicine chest. The Aquatic Animal Drug Approval Partnership program is part of the Fish and Aquatic Conservation’s fish health work and is the only program in the United States singularly dedicated to obtaining U.S. Food and Drug Administration approval of new medications needed for use in fish culture and fisheries management.  

Safe and effective medications improve the health of aquatic animals.  

When fisheries professionals have more options for medications, they are better equipped to rear healthy fish, manage healthy aquatic populations, and maintain a healthy environment. 

Since the late 1990’s, the Aquatic Animal Drug Approval Partnership has contributed to the majority of new fish medications approved by the FDA. Ultimately, this work 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. Since 1999 the Aquatic Animal Drug Approval Partnership’s National Investigational New Animal Drug Program has: 

• Conducted 13,000 studies to ensure medications are safe to aquatic animals. 
• Treated 1.5 billion aquatic animals. 
• Saved 50 million fish each year for restoration, recovery, recreation, or the dinner table. 

Aquatic Animal Drug Approval Partnership programs work to:

• Oversee the National Investigational New Animal Drug Program. 
• Work with sponsors towards new animal drug approvals. 
• Maintain an applied research program. 

The Aquatic Animal Drug Approval Partnership’s Outreach Program provides the U.S. aquaculture community with up-to-date information on the status, availability, and use guidance of aquatic animal medications.  This ensures they are safe, effective, and legal when used in aquaculture and fisheries management. 

The 30th Annual Aquaculture Drug Approval Coordination Workshop

Hosted by the USFWS AADAP Program, the 30^th Annual Aquaculture Drug Approval Coordination Workshop will take place in Bozeman, MT from July 22^nd- 25^th, 2024. Topics to be discussed include aquaculture drug approval research and the progress of associated efforts. Please contact Pamela Sponholtz with any workshop-related questions.  Read more about the 30^th Annual Aquaculture Drug Approval Coordination Workshop.

Resources for Aquaculturists 

Resources for Selecting Aquaculture Medications - The fields of aquaculture and fisheries science require safe and effective medications for treating fish diseases and managing fisheries—as well as information to help guide the professionals who administer these medications.  

Quick Desk Reference Guide to Approved Drugs for Use in Aquaculture - Need an easy-to-use resource to help you know what aquaculture drugs are approved by FDA and what they can be used for? Download the Quick Desk Reference Guide to Approved Drugs for Use in Aquaculture (updated July 2020).

Drug Research Information Bulletins - Drug Research Information Bulletins (DRIBs) are short (1-2 pages) that summarize studies the AADAP Research Team has conducted and briefly describe of the purpose of the study, the methodologies, and results/discussion. 

Our Programs and Research

New Animal Drug Approval Assistance Program

We assist sponsors in navigating the FDA’s New Animal Drug Approval process where needed. This involves helping a new sponsor start the approval process and helping current sponsors find ways to keep moving forward in the approval process.

Aquatic Animal Drug Approval Partnership Applied Research Program

Our applied research program conducts studies that evaluate the safety and efficacy of experimental medications. Results of these analyses are used to support U. S. Food and Drug Administration approval of the drug.

Outreach Program

Our researchers, physiologists, nutritionists, and veterinary scientists provide fisheries professionals with up-to-date information about existing and pending drug approvals, as well as extensive drug use guidance information.

National Investigational New Animal Drug Program 

The Aquatic Animal Drug Approval Partnership program sponsors a variety of medications through the U.S. Food and Drug Administration’s Investigational New Animal Drug pathway. Investigational New Animal Drugs are drugs that are in the approval pipeline but are not yet approved by FDA for use in the United States. They are strictly controlled by the FDA’s Center for Veterinary Medicine and the Service’s Aquatic Animal Drug Approval Partnership.   AADAP has a National Investigational New Animal Drug Program that is available to all fish culturists, fish biologists, and fishery managers within the United States and U.S. territories and allows participating facilities to have legal access to a broad variety of medications that are still in the approval process.

Learn more about Aquatic Animal Drug Approval 

How an Aquatic Animal Drug is Approved in the U.S. - Aquatic animal drug approval is a rigorous and expensive process that is necessary to ensure the effectiveness of the drug and its safety for fish, consumers, and the environment. For

Aquatic Animal Drugs Keep Fish Healthy - Safe and effective medications improve the health of aquatic animals. When fisheries professionals have more options for medications, they are better equipped to rear healthy fish, manage healthy aquatic populations, and maintain a healthy environment. 

Partners in the Aquatic Animal Drug Approval Partnership  - The Aquatic Animal Drug Approval Partnership Program works closely with the Association of Fish and Wildlife Agencies’ Drug Approval Working Group to provide a national perspective for the oversight and coordination of collaborative research, field tests, data collection, data analysis, and data submittals to the U.S. Food and Drug Administration.

Follow Along for Updates

The AADAP Updates feature news on aquaculture drugs currently in the U.S. Food and Drug Administration (FDA) approval process, AADAP programmatic updates, and aquaculture drug use guidance information. If you would like to sign up to receive the AADAP Update, please email pamela_sponholtz@fws.gov to be added to our email listserv. Thank you!