Summary of Previous Human Experience with the Investigational Drug (STATE CONTENTS)

1 IF NO PREVIOUS HUMAN EXPERIENCE EXISTS, should be stated in this section of the IND application. 2 IF AN INVESTIGATIONAL DRUG HAS BEEN INVESTIGATED OR MARKETED PREVIOUSLY, 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. 3 If the product has been marketed outside of the United States, all countries where the product has been marketed or withdrawn from any of those markets (and why) should be listed.