IND and IDE Submission and Review

Are you working on an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the Food & Drug Administration (FDA)? If so, the Clinical & Translational Science Institute (CTSI) can help. CTSI has developed an IND checklist and an IDE checklist for University of Minnesota investigators, as well as an overview of the FDA review process. CTSI's regulatory support team can even help you submit your application. CTSI is a Consortium member center.