FDA Submission Support

The IND/IDE Office will help you with FDA compliance

FDA Guidance Documents

Search guidance documents published on the FDA website

Submissions

Single Patient IND/IDE Submissions
Full IND/IDE Submissions

FDA’s Single Patient IND/IDE Pathway (for investigational new drugs and devices) allows use of an investigational drug, biologic, or device to treat a patient who:

Is suffering from a serious or immediately life-threatening disease or condition, and
Does not have comparable satisfactory alternative therapies, and
Cannot participate in a clinical trial.
If the risks associated with treatment are not unreasonable, and potential benefit justifies potential risks.

We can help treating physicians navigate this pathway for their patients who meet these criteria. We will facilitate the FDA application process, IRB Chair Review request, and institutional reviews. However, the treating physician will be the IND/IDE holder, and must comply with all regulatory, institutional, and manufacturer requirements in order to treat a patient under a single patient IND/IDE.

Submit to the Single Patient IND/IDE Portal

1

Fill this out ONLY if you have been prompted to do so by an IND/IDE program team member

2

If you need to save and return later, SAVE YOUR RETURN CODE

3

Once you have submitted, DOWNLOAD A PDF COPY OF YOUR SUBMISSION.

You will need it for IRB Chair Review

A research IND (also called a non-commercial IND) is one for which the sponsor (generally an individual investigator, academic institution or non-profit entity) does not intend to later commercialize the product. These studies are strictly for research, are usually shorter in duration and may result in publications in peer-reviewed journals. In comparison, a commercial IND is one for which the sponsor (usually a corporate entity) intends to commercialize the product by eventually submitting a marketing application.

For more information on developing an IND/IDE review the details on the IND/IDE webpage and complete the triage form.

Submit the IND/IDE Triage Form

Contact Us

All communications with the FDA now go through the IND/IDE program. They will be happy to engage and assist you to support your IND or IDE application.