Investigational New Animal Drugs (INADs) University - Senior Level

Senior Level: This section has advanced questions regarding the INAD Program. This material is intended for participants with technical questions regarding the INAD products, the INAD database, or those who are interested in the drug approval process.

Subject 1: INAD products

Do I need to use the INAD product listed in the study protocol even if there is a cheaper option from a different brand?

The drug suppliers listed on the INAD factsheet pages are working on the specific formulations which are in the approval process. Therefore, only their product can be used under an INAD treatment.
Is it possible for a drug to have both an approved use and an INAD use?

Yes, working with the INAD Program allows one to treat an unapproved use or indication using an unapproved drug. The same drug may also be approved by the FDA for treating specific indications and usages (i.e., species, dose, disease). Approved uses are not conducted through the INAD Program.

Example: Hydrogen Peroxide is approved to treat bacterial gill disease in salmonids, but not approved for external parasites in marine fish. Therefore, to treat external parasites in marine fish, you could use the Hydrogen Peroxide INAD while participating in the INAD Program.
Can INADs be used to prevent disease or illness in fish?

Preventative use is considered prophylactic treatment. You would need to check the INAD protocol to determine whether prophylactic use is allowed.

Subject 2: Database functions

How do I duplicate a study?

You can duplicate a study as a time-saving measure, if needed. To do this, select the study from the investigator’s account; scroll to the “Study Design” section and click the “Duplicate This Study” box; this will open a new duplicated study. Please be aware that you cannot duplicate a study which was closed out (i.e., cancelled).
Do I need to send fish health reports with INAD data?

Fish health reports are not required but they do make the INAD data stronger by providing additional supporting information and are highly encouraged. If available, you can attach a fish health report to the Results Report. In some cases, AADAP may request one.
How should I fill out the tables in the Results Report?

Please consolidate the data-entry tables as much as possible. Mortality Records can have the total number of mortalities for the day entered as one entry instead of each raceway; Spawning Records can have one line entry for treated females, treated males, and the same for controls; and Anesthetic Records can show the total number of fish treated each day (or if there are many days, then one entry/month).

Subject 3: INAD Data

How is the INAD data used and why is it important to follow the protocols?

The data collected from the INAD Program is used to support the Target Animal Safety and Efficacy sections, which are major technical sections required in the drug approval process. These technical sections provide evidence to the FDA regarding whether the drug was safe and effective for treating the indication (i.e., disease or use) in different fish species. Additionally, INAD data may be evaluated by drug sponsors looking to identify potential areas of need where the development of new drugs, or new indications for already-approved drugs, may be beneficial.
Why was my study sent back for edits?

A study will be sent back to a previous stage if any of the following occurs: the protocol was not properly followed, a required section within the Study Request or Results Report was not completed, a deviation was not addressed, data was missing, or information (i.e., dates, number of fish treated, number of days treated) was inconsistent throughout the form. Both the monitor and AADAP can send back studies.
If the disease or indication I intend to treat is not listed for the INAD, can this be added?

If you are interested in using an INAD for an indication that is not listed in the study protocol, contact AADAP. We will contact the drug sponsor and FDA for further information.
What do I do if I have a new drug that I want to have investigated for drug approval?

Contact AADAP to find out what the New Animal Drug Application process entails. You will need a committed drug sponsor before you can begin the application process.