What is an Investigational New Drug Application (IND)?

An Investigational New Drug Application (IND) is a formal submission to regulatory agencies, such as the U.S. Food and Drug Administration (FDA), seeking permission to start clinical trials on a new drug. This application provides essential information about the drug, including its composition, manufacturing, and the way it works, along with details about the proposed clinical study protocols. The primary goal of the IND is to ensure the safety and rights of clinical trial participants while also providing the necessary data for regulatory agencies to evaluate the clinical significance of the drug.

In contrast, a request to terminate a clinical trial pertains to ending an ongoing study, and would not fall under the scope of the IND process. A request for submission of a marketing application relates to the later stages of drug development when the manufacturer seeks approval to market the drug after successful completion of clinical trials. Funding requests are typically handled separately and do not form part of the IND requirements, as the IND focuses specifically on clinical trial initiation rather than financing those trials.