FDA IND and IDE Submissions

The UF Clinical and Translational Science Institute (CTSI) provides guidance on FDA Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, including:

  • Determination of product classification (i.e., drug, device, combination product, biologic)
  • Applicability of an IND or IDE
  • Assistance with submission of an IND or IDE application
  • Preparation, coordination, facilitation, and attendance at FDA meetings
  • Preparation for regulatory support during FDA inspections of investigator-sponsored clinical research
  • Provide information about new guidance documents, inspection trends, inspection actions and new regulatory actions taken by FDA relating to clinical research
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