The Investigational New Animal Drug Program University
What is an INAD?
Investigational New Animal Drugs (INADs) are drugs that are in the approval pipeline but are not yet approved by the Food and Drug Administration (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. Their use is approved so that meaningful data will be generated and used to support a New Animal Drug Application (NADA). Investigational New Animal Drugs are not “use permits”, when using an INAD the approved Study Protocol must be followed.
Why are INADs important?
Investigational New Animal Drugs provide fisheries managers access to otherwise unavailable drugs that are necessary to meet their current management needs (i.e., spawning aid, disease treatment, anesthetic). They generate important data demonstrating a drug’s safety and effectiveness. Investigational New Animal Drugs are available for any United States fisheries program and can be used nationwide, helping support broad (i.e., multiple species/pathogens) approvals.
Have questions about participating in the INAD Program? If so, scroll down to learn more at our INAD University. Otherwise, head back to our home page to learn more about our other fisheries programs!
Welcome to INAD University!
The information below is intended to help answer common questions that participants may have regarding the National INAD Program. The content is meant to help those individuals new to the program (i.e., freshman level) as well as those who have participated for a long time (i.e., senior), and everyone in-between. If you have a question that you cannot find, contact AADAP for further assistance.
Freshman Level: This material is intended for new participants looking to learn more about how the INAD Program works or participants that need a quick refresher on some of the basic INAD Program information.
To participate in the INAD Program you need to create an account with the INAD database
, designate two people to act as the investigator and monitor who will be responsible for reporting the data, review the required forms, and ensure that the study protocols laid out by the FDA are followed. You may also need to sign a cooperative agreement form (U.S. Fish and Wildlife Service [USFWS] facilities are exempt). Lastly, all data collected must be submitted to AADAP in a timely manner. 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.
All U.S. facilities (i.e., state, tribal, federal, university, or private agencies/facilities) are encouraged to participate.
Visit our “How to Enroll in the Investigational New Animal Drug Program
” page for step-by-step instructions to set up your account. As part of this enrollment process, each facility will select two individuals (an investigator and a monitor) to be involved in the data collection and data entry process. Further explanations of these study roles are explained at the link above.
Yes, a manual detailing how to use the online INAD database and complete the forms can be found in the database
. To access the manual, log into the INAD database and in the upper right-hand corner of the home page you will see an orange “MANUAL” option.
Each facility can only have one monitor and one investigator on their account. Other staff members can act as the investigator and enter information into the forms if needed, but only one person’s contact information can be saved in their account.
Each non-USFWS facility/office will be required to pay $700 to participate in the INAD Program for each INAD they plan to use per year. Participants are not limited to the number of studies conducted or the number of species they can treat using an INAD. This fee covers the program’s administrative costs.
If you cannot find the species you wish to treat listed in the drop-down menu, first check the INAD factsheet page
to ensure that treatment for the species is available under the INAD. If treatment is allowed for the species but it is not listed, please contact AADAP
with the species’ scientific and common names.
Yes! Enrollment only covers one calendar year and is not automatically renewed each year. If you no longer wish to participate in the program, you do not need to take any steps to terminate your enrollment. Keep in mind, you will be required to complete all documentation for the year of your enrollment.
Participation in the INAD Program requires an understanding of basic fish health and husbandry, typically acquired through years of experience. Having this knowledge ensures that each participant can properly treat the fish following the INAD protocols and collect the needed information, as well as recognize common fish diseases/pathogens. Working with your monitor or fish health professional for proper diagnosis of any fish disease is encouraged.
Please reach out to your local agriculture extension agent for information regarding raising fish and basic fish knowledge before joining the INAD Program. Other potential sources to contact could be local universities/colleges or facilities raising similar species.
INADs require calculations to determine correct dosing. AADAP’s Quick Desk Reference Guide to Approved Drugs for Use in Aquaculture
can be used to reference dosing and examples. Although it is your responsibility to calculate dosages correctly, when you submit your Study Request through the INAD database we will double check your proposed dose to ensure it is accurate and follows the study protocol. This is why it is important that you submit Study Requests prior
to initiating treatment.
The first person to contact regarding questions is your monitor, as it is their role to advise you through the required steps to participate in the INAD Program. If your monitor cannot answer your questions, contact AADAP
Contact your monitor or fish health professional. Disease treatments can sometimes be avoided by changing the water quality or reducing fish densities. If you need to conduct an INAD study, then reach out to an AADAP employee
When changes are made to your account information or your study is advanced to the next stage, you should receive an email notification from the INAD database. It is likely that these notifications may end up in your junk folder or your company may identify them as potential spam. Please check your junk folder or contact your IT department to ensure this is not happening.
All treatments conducted under an INAD are referred to as a study. There are seven stages of the study process as described below. If you have questions, please contact the appropriate individuals listed in the stages below.
Stage 1: Before treatment can begin, an investigator must fill out and submit a Study Request to the monitor.
Stage 2: The monitor will review and advance the Study Request to AADAP.
Stage 3: AADAP will review the Study Request, assign a study number, and advance it to the next stage.
Stage 4: Treatment can now begin. Once the treatment is completed and all data has been collected, the investigator then enters the data into the Results Report and submits it to the monitor.
Stage 5: The monitor will review the Results Report and advance the study to AADAP.
Stage 6: AADAP will review the study for the last time and determine if it can be approved.
Stage 7: The study will be archived in the database and accessible to study participants.
If information is missing, the protocol is not followed, or forms are not correctly filled out, both the monitor and AADAP can send a study back to a previous stage.
Sophomore Level: This material is intended for participants currently enrolled in the INAD Program who are looking for information on managing their online accounts or submitting Study Requests.
If you forgot your login information, it can be accessed by clicking the “Forgot Username/Password” on the INAD database homepage
. If you are a new investigator taking over the current account, contact AADAP to receive the login information.
Updating your contact information, enrollment, and fish species treated can all be done from the investigator’s “Account Info” page. To access this page, login to the investigator’s account on the INAD database
and click the “Account Info” tab on the top right of the page. Be sure to click the “Save Data” button at the bottom of the page to save the changes.
Replacing either the investigator or monitor is easy. First, share the login information of the previous investigator/monitor with the new individual. Once they log in, select the “Account Info” tab on the upper-right of the page. They can then update the contact information to reflect their own, as well as change the username and password. Replacing the investigator/monitor is preferred, rather than creating a new account. This will enable the new individual to access previously conducted studies.
You must enroll for each year that you wish to participate in the INAD Program. Enrollment takes place on the investigator’s “Account Info” page under the INAD Sign-up section. When enrollment is completed you will need to click on the “Save Data” button at the bottom of the page. You will be charged the INAD fee for each year that you enroll in the program.
First, you must submit a Study Request. Once AADAP assigns a study number (advances the study to Stage 4), we will notify the supplier that your facility has been approved to purchase the drug. You will then need to contact the supplier directly. Contact information for each supplier can be found on the INAD Fact Sheet
Each time that you receive the drug it is important that you enter a new drug receipt. To enter the drug receipt info, select the “Manage/View Drug Inventory” from the investigator’s homepage. From the “Manage/View Drug Inventory” page, click the “Receipt of Drug” in the brown box on the upper left of the page. Enter all information and click “Add To Drug Inventory” to save. Remember, you will need to repeat this process each time you receive the drug from the supplier.
Yes, extra INAD drug can be transferred to other facilities participating in the INAD Program. To transfer the drug, click “Manage/View Drug Inventory” from the investigator’s homepage; select the inventory to transfer; click the transfer button; fill out the information; and click save. The receiving facility will then need to enter the received drug into their inventory.
Please review the Safety Data Sheet (SDS) disposal section to determine how to best dispose of each INAD. You can find the SDS sheet on the INAD Fact Sheet page (Select the drug; click “Study Protocol” in blue text in the second paragraph; and in the table of contents you can click on the SDS section).
You will need to edit the drug receipt information in your account to notify AADAP that the drug was discarded. To do this, click on the “Manage/View Inventory” page in the INAD database; click “Discard”; enter the date and amount to discard; then click “OK” to save the changes.
Prior to beginning treatment, you and your monitor must first identify the specific needs of the fish and determine which INAD will be most appropriate for use. Then you will need to submit a Study Request in the INAD database. AADAP will assign a study number to your request at which point you can begin to initiate treatment.
A study number is assigned by AADAP to each treatment (or study) conducted under an INAD. This allows us to track and reference each individual study while it is taking place and after it is completed. Only AADAP can edit the study number.
A VFD is not needed when working with the INAD Program. For medicated feed INADs we ask that you provide the contact information for the feed mill you would like to work with in your Study Request form. AADAP is responsible for contacting feed mills and notifying them of your approved use of their product under the INAD.
The FDA allows for compassionate use if there is a disease outbreak which threatens the livelihood of your fish. If such event occurs, and you have not already submitted a Study Request, contact your monitor to work out a treatment plan which follows the required protocol. Begin treating your fish and submit a Study Request ASAP. Then notify AADAP of the circumstances.
A new study number is needed (e.g., a new Study Request will need to be submitted) anytime a new therapeutic or sex reversal treatment is initiated. If the start date of treatments will be staggered over multiple days, then each treatment will need its own study number. For anesthetic, marking, or spawning INADs there are different guidelines. Generally, a new study number will be needed if there are more than 30 days between treatments, different doses will be used, or the treatment crosses into the new year by more than two weeks.
AADAP will let you know if you need to break your studies into multiple study numbers after reviewing the Study Request. If treatments have already occurred there may be occasions where we request the study be broken into multiple study numbers so the data can be better evaluated. Please keep in mind that large or long studies may require multiple Study Request forms to be submitted.
If the species you plan to treat is not listed in the drop-down menu on the Study Request form, this means that you have not enrolled in the INAD to treat that species. You can add enrollment to treat the species on the investigator’s “Account Info” page. Scroll to the bottom of the form and add the species to the enrollment table. Once this is done, click on the Save Data button and the species will appear in the study request drop-down menu.
Controls, or non-treated control fish, are not required in INAD studies, as we understand that fish numbers are often limited. However, adding controls to INAD data provides strong support for whether the drug was effective. When possible, controls are encouraged.
Since controls are not used in the majority of INAD studies, we cannot truly calculate the percentage of fish which were saved due to the INAD treatment. However, we do ask that investigators provide an estimate of the percentage of fish they believe were saved due to INAD use. This estimate can be based on past facility history or mortality rates prior to treatment.
Junior Level: This material covers more advanced questions regarding data entry, how to properly complete the Results Report, and which species can be treated under an INAD.
Study result forms are due 30 days after the last day of treatment. Some INADs require mortality data to be collected for 10 days post-treatment, laboratory tests to be conducted and included in the results (i.e., ELISA tests), or post-hatch evaluation of progeny; in those circumstances we ask that you submit the study Result Report no later than 30 days after all data has been collected.
To close out a study that was not conducted; click on the study from the investigator’s account and select “No” from the “Was Treatment Initiated” banner located at the top of the page. Provide a reason for why the study was not conducted and click “Save Changes” at the bottom of the form.
Please be aware that studies will never be removed from the database, even if they are closed out, as we are required to keep records of all studies regardless of whether they are initiated.
If data is lost, you are still required to complete the Results Report by providing your best estimates for all the required fields. Please provide the reasoning for why true data was not reported in the “Description of Results” section as well as the “Study Deviation” section in the Results Report.
If you do not report your data in a timely fashion, AADAP will contact you. If you do not respond and your data is not submitted by the end of the year, AADAP will complete the form using estimates. Your facility will then be removed from the INAD Program and will no longer be allowed to participate in the program. Such facilities will be reported to the FDA and to the drug sponsor.
Any changes from the FDA approved study protocol are considered deviations and need to be reported in the “Study Deviation” section on the Results Report.
Example: The number of treatment days in your study differs from what is allowed in the protocol.
If you know that a deviation will occur, contact your monitor and AADAP
before initiating treatment. We will ensure that the FDA’s protocol is largely being followed. Some deviations will require AADAP to contact the FDA and ask for permission. If a deviation is found after treatment has occurred, this needs to be reported to the monitor and AADAP as soon as possible, as well as documented in the Results Report form.
if you are interested in concomitant use, as some INADs allow this. However, most INADs cannot be paired with other drugs (approved or unapproved). This enables us to ensure that we can adequately determine the effectiveness of individual drugs.
First check the protocol to make sure re-treatments are allowed. If they are, you must wait at least 14 days between INAD treatments. If your fish will not survive without immediate treatment, contact AADAP
. If fish are re-treated before the 14-day period, a deviation will need to be reported in the “Study Deviation” section in the Results Report.
AADAP can only allow use of our INADs on aquatic animals that are listed in the FDA Food Use Authorization letter. Fish are the focus of most of AADAP’s INAD use. However, certain INADs have been used to treat shrimp, lobster, mussels, oysters, and sharks. Please contact AADAP
if you’re interested in treating a species not listed in the INAD’s protocol.
If you are working with a federally listed threatened or endangered species, you need to use either an INAD or an approved drug for treatment. If you need to use a drug that is not an INAD or is unapproved, contact AADAP
for more information.
All INADs have been reviewed by the FDA and assigned a withdrawal period which must be maintained before the treated fish can be released. The withdrawal period ensures that if captured, treated fish would be safe for human consumption. If a withdrawal period is not listed in the protocol, then fish treated with the INAD cannot be used for human consumption. This is another reason why carefully reading through the study protocol prior to initiating treatment is important.
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.
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.
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.
Preventative use is considered prophylactic treatment. You would need to check the INAD protocol
to determine whether prophylactic use is allowed.
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).
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.
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).
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.
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 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.
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.
Resources: In this section you will find instructional and educational resources to aid those interested or currently working with the INAD Progam. These guides describe each step of the INAD process and are intended to help investigators and monitors in their roles to meet the requirements of the INAD Program.
This document is intended for a new investigator taking over an already existing investigator account. There are more detailed documents available, but this instruction sheet is intended to be short and to the point on what needs to be completed in this role. For more information on the INADs please visit the AADAP INAD website
The Investigational New Animal Drug Program – Investigator Quick Notes
As the monitor your job involves assisting the Investigator to complete all necessary steps of the INAD process including reviewing the Study Requests and Results Report before submitting them to AADAP. We encourage Investigator’s to reach out to their Monitor with questions prior to contacting AADAP. This guide is intended to provide Monitor’s with the information needed to help answer those questions and aid them in the INAD process.
The Investigational New Animal Drug Program – Monitor Guide