The National Investigational New Animal Drug Program is operated by the Aquatic Animal Drug Approval Partnership. 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, Aquatic Animal Drug Approval Partnership Program has contributed to the majority of the new fish medications approved by the FDA.
What are INADS?
Investigational New Animal Drugs (INADs) are drugs or medications that are in the approval pipeline but are not yet approved by FDA for use in the United States. In fish science, the term “drug” is used to recognize more than just fish medication, it also includes disinfectants, pesticides, herbicides, and biologics. Participants who enroll in the INAD program are allowed legal access to these drugs under highly controlled and monitored usage. The data they collect is then used as a part of the FDA drug approval process.
Who benefits from INADS?
Investigational New Animal Drugs provide fish culturists, fish health biologists, and fishery managers with legal access to a broad variety of medications that are still in the approval process. They keep fish and other aquatic animals healthy by treating diseases caused by parasites and bacteria, sedating animals so that they may be safely handled, and assisting in spawning animals that would otherwise not spawn on their own.
Who should participate in the program?
The program is open to anyone; however, the strict laboratory, staffing, and reporting guidelines are most appropriate for:
- Researchers at academic institutions
- Tribal, state or federal hatchery managers
- Private aquaculturists with significant capacity
- Zoos and Aquariums
What does it cost to take part in the program?
- Each non-USFWS facility/office will be required to pay $700 to participate for each INAD they plan to use per year. Participantsare generally not limited to the number of studies conducted or adding multiple species to treat for each INAD. Specific information regarding how each INAD can be used can be found in the study protocol.
What are the general requirements for enrolling in the program?
- Create an account with the INAD database. (NOTE: Successful participation requires two people to be signed up in the database - one investigator and monitor.)
- Validate program requirements with the INAD Program coordinator and review the full program documentation. Upon signing up for the INAD Program, you will receive a step-by-step guide as to what is expected from you to participate in the INAD Program via email.
- Enter into a Cooperative Agreement if one is not already established.
- Enroll in individual INADs and pay annual enrollment fees. You must enroll in and pay a fee for each INAD separately each year.
- The INAD Program runs on a calendar year. While enrollment can happen at any time, studies and reports must be completed by the end of the calendar year.