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IND/IDE FDA Submissions & File Maintenance

Published on Jul 10, 2019 · Last Updated 4 months 3 weeks ago
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The Investigational New Drug and Device Support Program maintains institutional history of all IND and IDE submissions to the FDA. It is the responsibility of the sponsor to provide all correspondence with the FDA to the IND/IDE Support Office to maintain the institutional file.

The IND/IDE Support Office also assists with study start up, maintenance, and close out 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
Request more information

The IND/IDE Support Office will provide support for correspondence with the FDA, and as the holder of the institutional records for FDA correspondence, sponsors and study teams are required to provide the IND/IDE Support Office with all FDA correspondence documentation. This includes reporting requirements such as annual reports, protocol deviations (amendments, SAEs, etc.) and study close out.

As the IND or IDE Sponsor, you are responsible for reporting the following information to the FDA: ­

  • Protocol changes
  • Updates in information contained on the Form FDA 1572 or Investigator Agreement (i.e. changes to the study team or sites/satellites of the investigation)
  • Updates in safety information about the drug or device
  • Updates in manufacturing, controls, or results of tests conducted on the drug or device
  • Annual reports
  • Change in investigators or change in the Sponsor or Primary Point of Contact (PPOC) and/or address
  • Transfer of Obligations
  • Completion or termination of a trial (Clinical study report)
  • New trials under the IND or IDE
  • Closure of the IND or IDE

Visit FDA.govand search for the most recent guidance for:

  • FDA Adverse Event Reporting Guidance
  • FDA: IDE Unanticipated Adverse Device Effects
  • FDA Final Rule: IND Safety Reporting Requirements
  • Safety Reporting Requirements for IND and BA/BE Studies
  • FDA: Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities

FDA IND Application Guidance

Find general FDA guidance regarding IND application management and reporting requirements at the FDA's IND Application .

FDA IDE Application Guidance

Find general FDA guidance regarding IDE application management and reporting requirements at the FDA's IDE Application.

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