Help us optimize this website! A couple minutes of your time could help us make information architecture and design improvements. Take our user experience survey.

What is On-Label Use?

“On-label use” means the drug is being used in the same indication, dose, route of administration, patient populations, and drug formulation. There is no deviation from the approved FDA label. Studies involving the on-label use drug do not require an IND, as long as data will not be used in a marketing application.

FAQ Page

Subscribe to the UArizona Impact in Action newsletter to receive featured stories and event info to connect you with UArizona's research, innovation, entrepreneurial ventures, and societal impacts.

Subscribe now