IND & IDE Support FAQs

The FDA communicates directly with the Sponsors of IND and IDE applications and holds these communications confidential.  Therefore, the FDA does not include or copy the University on these communications.  However, the University of Pittsburgh is potentially liable for the actions of its faculty members, thus necessitating that the University be engaged in the communications.  The University must be involved in the oversight and must also ensure appropriate monitoring of the progress and appropriate conduct of these types of clinical trials.

Contact IIS at IIS@pitt.edu if you have additional questions.

If an investigator thinks the study meets all the IND exemption criteria, then, appropriate justification (based on the IND exemption criteria) must be provided to the IRB.   The IRB may decide that the study can be conducted without an IND.  If the reviewing IRB is unsure whether the study can be conducted without an IND, they can require the investigator to submit to the FDA for a determination.  The FDA’s determination is binding.

Contact IIS at IIS@pitt.edu if you have additional questions.

For a change in Investigator or the addition of a new Investigator at an external site, the FDA must be prospectively notified within 30 days of the investigator being added.  For sub-investigator changes, prospective notification is not necessary; however, this information should be included with the next Annual Report and the Form FDA 1572 should be updated in the regulatory file.    

Contact IIS at IIS@pitt.edu if you have additional questions.

In general, because an IND/IDE is for a product, multiple protocols may be submitted under an existing IND/IDE.  There are two instances where this would not be permitted.

1. The study is being conducted under the Exemption from Informed Consent (EFIC) regulations.
2. The indication for use requires review by a different FDA Division than the original protocol.

Contact IIS at IIS@pitt.edu if you have additional questions.

For studies conducted under an IND, it is recommended that you first submit to the IRB.  Upon IRB approval, a submission to the FDA should be prepared as single PDF file and forwarded to the IIS service account IIS@pitt.edu.  IIS will submit electronically on the Sponsor’s behalf.  Please note: All FDA IND submissions must include a completed Form FDA 1571 signed and dated by the sponsor.

For studies conducted under an IDE, it is recommended that you first submit to the FDA. A single PDF or multiple PDFs may be submitted to the IIS service account IIS@pitt.edu.  IIS will submit the required eCopy format electronically on the Sponsor’s behalf.  Please note: All FDA IDE submissions must include a signed and dated cover letter.

Depending on the circumstances, for either an IND or IDE, the submission may be made to the FDA first or concurrently with the IRB.

Contact IIS at IIS@pitt.edu if you have additional questions.

There is no wait time to implement protocol changes after IRB approval and the change in protocol submitted to the FDA.  However, it should be noted that the FDA may issue comments on the revised protocol.  IIS has seen FDA issue comments anywhere from 45 days to several months after submission.

Contact IIS at IIS@pitt.edu if you have additional questions.

There is no wait time to implement a new protocol after IRB approval and the new protocol submitted to the FDA.  However, it should be noted that the FDA may issue comments on the new protocol.  IIS has seen the FDA issue comments anywhere from 45 days to several months after submission.

Contact IIS at IIS@pitt.edu if you have additional questions.

Yes, the Sponsor must wait for FDA approval of the Supplement before implementing protocol changes.  In the case of minor protocol changes, a Notice of IDE change (i.e., 5-day Notice) may be submitted, but no later than 5 working days after making the change.  Contact IIS at IIS@pitt.edu for additional guidance on IDE changes.