Investigational New Drug Application (IND)
Drug developers file an IND, or Investigational New Drug Application, prior to beginning clinical trials. An IND is technically an application for drug developers to be allowed to ship a not-yet-approved drug across state lines. In practice, an IND offers the FDA an opportunity to analyze the safety and effectiveness of a new experimental drug and determine whether or not human testing of that drug should be allowed to proceed. An IND contains information on animal testing and toxicology, manufacturing information, and the drug developers’ plans for clinical trial design and management. Once the FDA decides that an applicant’s experimental drug is not likely to be unreasonably harmful, developers can begin human clinical testing.