Once your study protocol and informed consent form have been approved by an IRB, the next step is to submit an Investigational New Drug (IND) application to the FDA. This application provides detailed information about the drug or device being studied, the study design, and the safety and efficacy data collected to date. The FDA reviews the IND application to ensure that the proposed study meets ethical and scientific standards, and that the potential benefits outweigh the risks. If the IND application is approved, the trial can proceed to the next phase.