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Assistance with IND/IDE FDA Submissions & File Maintenance

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The Investigational New Drug and Device Support Program maintains institutional history of all of CHOP’s IND/IDE submissions to the FDA. It is the responsibility of the sponsor-investigator to provide all correspondence with the FDA to the IND/IDE Support Office to maintain the institutional file.

The IND IDE Office also assists with study start up, maintenance, and withdrawal including:

  • FDA submission document review
  • FDA submission document completion
  • Guidance on communicating with the FDA
  • Assistance with package submission to the FDA
  • Reminders of upcoming annual reports
  • Guidance on amendment submission requirements