Applying to use an investigational drug or device outside of a clinical trial on a case-by-case basis can be difficult. The FDA has provided a streamlined process to aid investigators and ensure subjects receive the care they need.

Expanded Access / Emergency IND and IDE Applications

Applying to use an investigational drug or device outside of a clinical trial on a case-by-case basis can be difficult. The FDA has provided a streamlined process to aid investigators and ensure subjects receive the care they need.

While a traditional IND or IDE application can be used, FDA Form 3926 may be an easier approach for investigators.

Although a clinical investigation is not taking place under an Expanded Access IND or IDE, investigators are still responsible for all federal regulations that apply to INDs/IDEs. Major responsibilities are listed below. Please consult a regulatory expert and 21 CFR 312 or 812 for a complete listing.

  • Ensure IRB and FDA approval prior to treatment
  • Obtain appropriate informed consent
  • Maintain accurate and complete treatment and regulatory documentation
  • Report SAEs to IRB and FDA
  • Submit annual reports as necessary to FDA
  • Formally close out IND/IDE with the FDA when treatment is complete

If you have any questions regarding Expanded Access submissions, please contact Amanda Wood.

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