What is an investigational new drug (IND)?

An investigational new drug (IND) is defined as a request for authorization from the FDA to administer a drug to humans for the first time. This designation is essential as it marks the transition of a potential drug from preclinical development to clinical trials involving human subjects.

Once a company or sponsor has sufficient data from laboratory and animal studies indicating that a drug may be safe for human use, they must submit an IND application. This application includes detailed information about the drug's composition, manufacturing, and proposed clinical study protocols, ensuring that all necessary safety and ethical considerations are addressed before human trials begin.

The process of obtaining an IND is critical for protecting human participants and fosters rigorous scientific evaluation, contributing to the overall goals of the FDA’s drug approval process. Understanding this concept is vital, as it underscores the regulatory framework that governs the development of new therapeutic agents and ensures that they are both effective and safe for public use.