There is no specific format for describing previous human experience with an investigational drug in an IND application. Shown below are some helpful points to consider when writing a summary of previous human experience:
If no previous human experience exists, this should be stated in this section of the IND application.
If an investigational drug has been investigated or marketed previously, either in the United States or other countries, detailed information about such experience that is relevant to the safety of the proposed investigation or to the investigation’s rationale should be included in this section. A summary of previous human experience should contain all relevant information about previous investigations or marketing, including clinical trial reports and published material relevant to the product’s safety and effectiveness.
If the product has been marketed outside of the United States, all countries where the product has been marketed or withdrawn from any of those markets (and why) should be listed.
For an IND application with investigational new drug that is subject to another existing IND application (e.g., an IND application sponsored by the investigational new drug’s manufacturer), the investigator-sponsor may obtain a Letter of Authorization from the existing IND sponsor with the right of reference to the information contained in the existing IND application, including information related to any previous human experience.
If an investigational new drug is a combination of drugs previously investigated or marketed, the description of human experience should be provided for each active drug component. However, if any component in such combination is an approved marketed product, submission of a copy of prescribing information leaflet may be sufficient. Additional published material about the approved drug may need to be submitted, if such material relates directly to the proposed investigational use (including publications relevant to component-component interaction).