What does an IND application allow?

An IND (Investigational New Drug) application is a submission made to the FDA that allows a sponsor to begin testing a new drug or biological product in humans. This process serves as a crucial step in the drug development pathway, ensuring that the proposed studies will be scientifically sound and that the rights and safety of human subjects are protected.

By obtaining an IND, the sponsor can legally administer the drug to human subjects in clinical trials, which is essential for determining the effectiveness and safety of the new treatment before it can be marketed. This application typically includes data from preclinical studies, the proposed study protocol, and information on the manufacturing processes and how the drug will be handled during trials.

The other options do not accurately reflect the purpose of an IND. For example, while drug marketing approval is obtained separately through a New Drug Application (NDA), making a drug available over-the-counter pertains to a different regulatory pathway. Researching drug interactions may form part of the studies in the clinical trial but is not the primary function of the IND application.