Frequently Asked Questions (FAQs)
1. What is an INAD?
An INAD (Investigational New Animal Drug) allows the legal use of unapproved drugs under limited and experimental conditions. They are strictly controlled by FDA’s Center for Veterinary Medicine (CVM) and AADAP. They are granted by CVM with the expectation that meaningful data will be generated and used to support a New Animal Drug Application (NADA). What they are not is a “use permit”. In other words you can not use an INAD anyway you want to. You must follow the approved Study Protocol.
2. Why are INADs important?
INADs provide fisheries managers access to otherwise unavailable drugs that are necessary to meet their current management needs. They generate important supportive data demonstrating a drug’s safety and effectiveness. INADs are available for any United States fisheries program. Based on this nationwide INAD-use, they help support broad (i.e., multiple species/pathogens) approvals.
3. What is the Study Protocol and why do I have to follow it?
All Study Protocols have been approved by FDA and they are required to receive a treatment use authorization to treat animals. Each Study Protocol contains all pertinent information regarding drug acquisition, fish treatment and disposition, data collection, etc., etc. If an Investigator is not able to follow the Study Protocol then they will not be able to participate under the INAD Program.
4. Why should I work with the AADAP Office?
The AADAP Office most likely has the largest most successful INAD Program. We provide fisheries managers access to drugs to meet current management needs. We have collected and used INAD data to support label claims. We have positive feedback from INAD Participants. And we work hard to make the INAD process easier for you.
5. Help my fish are sick and I don’t know what to do. What INAD should I use on them?
First we are very sorry to hear you have sick fish; however, please contact your fish health person or fish veterinarian for help. They will be able to help diagnose what is wrong with your fish and recommend the best course of action. It could be that a change in fish culture practice is needed and the fish will recover on their own. If it is decided that an INAD is needed then contact the AADAP Office and we will help you out.
6. What happens to the INAD study reports after I complete them in the online INAD database?
All study reports are reviewed by the AADAP Office. Quarterly and Annual Reports are submitted to CVM containing some of the following data collected from the field: fish species tested; number of fish tested; where the studies took place; drug dose used; if the studies were efficacious; any deviations that occurred; any fish toxicity or adverse behavior; and if the withdrawal times were met. We have also been able to use field studies to support the completion of Technical Efficacy Sections which results in new labels or expand the current labels.
7. What is the difference between the Study Monitor and the Investigator?
The Investigator and Monitor can not be the same person. Investigators are responsible for conduct of studies and complete and accurate data collection. The investigator account is where the data entry occurs. Study Monitors are responsible for supervision of the trials, adherence of the Investigator to the Study Protocol, and inspection of the site. Study monitors can only review/reject/advance studies through their accounts.
8. The fish species I want to treat is not listed in the drop-down list in my investigator account. What do I do?
Please check to make sure you have added that fish species to your list in the investigator’s Account Info section. However, if you are trying to add the fish species in the Account Info section and it is not showing up for that particular INAD you will need to contact the AADAP Office. Treatment authorizations are granted for certain fish species and yours may need to be added to this list; or it could be a fish species we have never had participate under the INAD program before.
9. My facility will have multiple Investigators. Will each Investigator need to create their own account?
No. Only one account is created for each facility. The User Name and Password will be used by all Investigators at the facility. You may either appoint a Lead Investigator that will enter all INAD study information or you can have each Investigator enter their own study information. The exception to this is if there are multiple facilities/offices. Then each facilities/offices needs its own investigator account created and to track the INAD use themselves.
10. What do I do if I want to change my Study Monitor?
You can change your Study Monitor in your Account Info section of your account as long as there are no studies in Stages 2-5. Any study already in progress will need to be completed by your current Study Monitor before you can select a new one. If your Study Monitor has left while studies are in progress please contact the AADAP Office.
11. Will I need to create a new facility account if the Investigator leaves the facility?
No. The User Name and Password are designated for the facility and not by Investigator. You can update the Investigator information in the Account Info section. Please contact AADAP to receive the User Name and Password if the investigator left without providing you this information.
12. I have received OTC Medicated Feed that will be used for both INAD and Legal Label use. How do I record this in the Drug Receipt and Drug Inventory section?
You may enter only the amount of OTC Medicated Feed that will be used for INAD use in the online INAD database. If you are unsure, then you can enter the entire amount under the INAD use and then Transfer out the amount of drug you use for Legal Label use.
Aquaculture and Aquaculture Drug Basics
Have you ever wondered where the koi in your local park’s pond come from, or the bettas at the pet store, or the tilapia at the grocery store? Have you ever thought about what happens if fish get sick? Are there drugs available to treat them?
Read below to find the answers to these questions and to find out more about the field of aquaculture.
https://www.fda.gov/AnimalVeterinary/ResourcesforYou/AnimalHealthLiteracy/ucm213944.htm#environment