IND Submission Process to the US FDA

An IND can be submitted by the sponsor/investigator at any phase of the clinical trial stage but must be submitted prior to testing the experimental drug in human participants. Figure 4 shows the steps for submission of the IND application to the FDA using the eCTD format for electronic submissions.

Following receipt of the eCTD submission to the FDA, the FDA has a 30-day period to respond. The FDA can be in constant communication during this period to clarify any concerns or doubts about the study. If there is no response from the FDA during this window, the study can proceed. Otherwise, the FDA can place the study on partial hold or clinical hold which can be due to inadequate data in the submitted IND or safety concerns. It is the responsibility of the sponsor/investigator to address questions that the FDA has posed and respond to these in a separate submission to the FDA. The FDA can either lift the clinical hold