About this Collection
How to Enroll in the Investigational New Animal Drug (INAD) Program: A tutorial that outlines the process of enrollment for study monitors and study investigators.
INAD University: Information 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.
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.