Drug developers file an IND, or Investigational New Drug Application, prior to beginning in-human clinical trials. An IND is technically an application for drug developers to ship a not-yet-approved drug across state lines. In practice, an IND offers the Food and Drug Administration (FDA) an opportunity to analyze the safety and efficacy of a new experimental drug and determine whether or not human testing of that drug should be allowed to proceed. An IND contains information from pre-clinical studies such as results from animal testing and toxicology studies, manufacturing information, and the drug developer’s 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.